Time Frame |
From first dose to 30 days after the last dose of study drug (assessed up to July 2016, approximately 55 months)
|
Adverse Event Reporting Description |
Adverse event data was only collected by cohort and not by dose. All participants in "Arm C10: Nivolumab (10 mg/kg) + Paclitaxel + Carboplatin" and "Arm C5: Nivolumab (5 mg/kg) + Paclitaxel + Carboplatin" were monitored for adverse events under a single "Arm C" as a cohort.
|
|
Arm/Group Title
|
Arm A: Nivolumab + Gemcitabine + Cisplatin
|
Arm J: Nivolumab + Ipilimumab
|
Arm K: Nivolumab In Squamous Histology Subjects (NSCLC)
|
Arm L: Nivolumab In Non-squamous Histology Subjects (NSCLC)
|
Arm M: Nivolumab
|
Arm N: Nivolumab + Ipilimumab
|
Arm O: Nivolumab + Ipilimumab
|
Arm P: Nivolumab + Ipilimumab
|
Arm Q: Nivolumab + Ipilimumab
|
Arm B: Nivolumab + Pemetrexed + Cisplatin
|
Arm C: Nivolumab + Paclitaxel + Carboplatin
|
Arm D: Nivolumab + Bevacizumab Maintenance
|
Arm E: Nivolumab + Erlotinib
|
Arm F: Nivolumab
|
Arm G: Nivolumab + Ipilimumab
|
Arm H: Nivolumab + Ipilimumab
|
Arm I: Nivolumab + Ipilimumab
|
Arm/Group Description |
Chemotherapy-naive SQ subjects; GEM...
|
Chemotherapy-naive NSQ subjects; Ni...
|
SQ subjects who completed >= 4 cycl...
|
NSQ subjects who completed >= 4 cyc...
|
Subjects with any histology and unt...
|
Chemotherapy-naive subjects with an...
|
Chemotherapy-naive subjects with an...
|
Chemotherapy-naive subjects with an...
|
Chemotherapy-naive subjects with an...
|
Chemotherapy-naive NSQ subjects; do...
|
Chemotherapy-naive subjects with an...
|
NSQ subjects who completed >= 4 cyc...
|
Chemotherapy-naive, subjects with E...
|
Chemotherapy-naive subjects with an...
|
Chemotherapy-naive SQ subjects; Niv...
|
Chemotherapy-naive NSQ subjects; Ni...
|
Chemotherapy-naive SQ subjects; Niv...
|
Arm/Group Description |
Chemotherapy-naive SQ subjects; GEM 1250 mg/m2 Days 1 and 8 with CIS 75 mg/m2 on Day 1 of a Q3W cycle for up to 4 cycles + Nivo 10 mg/kg Q3W until progression after cycle 4
|
Chemotherapy-naive NSQ subjects; Nivo 3 mg/kg + Ipi 1 mg/kg Q3W for 4 cycles followed by Nivo 3 mg/kg Q2W until progression
|
SQ subjects who completed >= 4 cycles of chemotherapy and are nonprogressors; Nivo 3 mg/kg Q2W as switch maintenance therapy until progression
|
NSQ subjects who completed >= 4 cycles of chemotherapy and are nonprogressors; Nivo 3 mg/kg Q2W as switch maintenance therapy until progression
|
Subjects with any histology and untreated, asymptomatic brain metastases; Nivo 3 mg/kg Q2W until progression
|
Chemotherapy-naive subjects with any histology; Nivo 1 mg/kg + Ipi 1 mg/kg Q3W for 4 cycles followed by Nivo 3 mg/kg Q2W until progression
|
Chemotherapy-naive subjects with any histology; Nivo 1 mg/kg Q2W + Ipi 1 mg/kg Q6W until progression or unacceptable toxicity
|
Chemotherapy-naive subjects with any histology; Nivo 3 mg/kg Q2W + Ipi 1 mg/kg Q12W until progression or unacceptable toxicity
|
Chemotherapy-naive subjects with any histology; Nivo 3 mg/kg Q2W + Ipi 1 mg/kg Q6W until progression or unacceptable toxicity
|
Chemotherapy-naive NSQ subjects; dose de-escalation design; PEM 500 mg/m2 with CIS 75 mg/m2, both on Day 1 of a Q3W cycle for up to 4 cycles + Nivo 10 mg/kg Q3W until progression after cycle 4
|
Chemotherapy-naive subjects with any histology; dose de-escalation design; PAC 200 mg/m2 with CAR AUC 6, both on Day 1 of a Q3W cycle for up to 4 cycles + Nivo 10 mg/kg Q3W until progression after cycle 4
|
NSQ subjects who completed >= 4 cycles of chemotherapy and are nonprogressors; BEV 15 mg/kg + Nivo 5 mg/kg Q3W until progression
|
Chemotherapy-naive, subjects with EGFR mutations; ERL 150 mg PO, daily + Nivo 3 mg/kg Q2W until progression
|
Chemotherapy-naive subjects with any histology; Nivo 3 mg/kg Q2W until progression
|
Chemotherapy-naive SQ subjects; Nivo 1 mg/kg + Ipi 3 mg/kg Q3W for 4 cycles followed by Nivo 3 mg/kg Q2W until progression
|
Chemotherapy-naive NSQ subjects; Nivo 1 mg/kg + Ipi 3 mg/kg Q3W for 4 cycles followed by Nivo 3 mg/kg Q2W until progression
|
Chemotherapy-naive SQ subjects; Nivo 3 mg/kg + Ipi 1 mg/kg Q3W for 4 cycles followed by Nivo 3 mg/kg Q2W until progression
|
|
|
Arm A: Nivolumab + Gemcitabine + Cisplatin
|
Arm J: Nivolumab + Ipilimumab
|
Arm K: Nivolumab In Squamous Histology Subjects (NSCLC)
|
Arm L: Nivolumab In Non-squamous Histology Subjects (NSCLC)
|
Arm M: Nivolumab
|
Arm N: Nivolumab + Ipilimumab
|
Arm O: Nivolumab + Ipilimumab
|
Arm P: Nivolumab + Ipilimumab
|
Arm Q: Nivolumab + Ipilimumab
|
Arm B: Nivolumab + Pemetrexed + Cisplatin
|
Arm C: Nivolumab + Paclitaxel + Carboplatin
|
Arm D: Nivolumab + Bevacizumab Maintenance
|
Arm E: Nivolumab + Erlotinib
|
Arm F: Nivolumab
|
Arm G: Nivolumab + Ipilimumab
|
Arm H: Nivolumab + Ipilimumab
|
Arm I: Nivolumab + Ipilimumab
|
|
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Total |
--/-- |
--/-- |
--/-- |
--/-- |
--/-- |
--/-- |
--/-- |
--/-- |
--/-- |
--/-- |
--/-- |
--/-- |
--/-- |
--/-- |
--/-- |
--/-- |
--/-- |
|
|
Arm A: Nivolumab + Gemcitabine + Cisplatin
|
Arm J: Nivolumab + Ipilimumab
|
Arm K: Nivolumab In Squamous Histology Subjects (NSCLC)
|
Arm L: Nivolumab In Non-squamous Histology Subjects (NSCLC)
|
Arm M: Nivolumab
|
Arm N: Nivolumab + Ipilimumab
|
Arm O: Nivolumab + Ipilimumab
|
Arm P: Nivolumab + Ipilimumab
|
Arm Q: Nivolumab + Ipilimumab
|
Arm B: Nivolumab + Pemetrexed + Cisplatin
|
Arm C: Nivolumab + Paclitaxel + Carboplatin
|
Arm D: Nivolumab + Bevacizumab Maintenance
|
Arm E: Nivolumab + Erlotinib
|
Arm F: Nivolumab
|
Arm G: Nivolumab + Ipilimumab
|
Arm H: Nivolumab + Ipilimumab
|
Arm I: Nivolumab + Ipilimumab
|
|
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Total |
4/12 (33.33%) |
12/16 (75.00%) |
3/13 (23.08%) |
4/13 (30.77%) |
4/12 (33.33%) |
12/31 (38.71%) |
21/40 (52.50%) |
25/38 (65.79%) |
25/39 (64.10%) |
10/15 (66.67%) |
17/29 (58.62%) |
3/12 (25.00%) |
11/21 (52.38%) |
23/52 (44.23%) |
6/9 (66.67%) |
12/15 (80.00%) |
5/9 (55.56%) |
Blood and lymphatic system disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Anaemia |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
2/38 (5.26%) |
1/39 (2.56%) |
0/15 (0.00%) |
4/29 (13.79%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
1/9 (11.11%) |
Bandaemia |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
1/29 (3.45%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Febrile neutropenia |
0/12 (0.00%) |
0/16 (0.00%) |
1/13 (7.69%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
3/29 (10.34%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Cardiac disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Atrial fibrillation |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
1/31 (3.23%) |
1/40 (2.50%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Atrioventricular block |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
1/38 (2.63%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Cardiac failure |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
1/52 (1.92%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Myocardial infarction |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
1/31 (3.23%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Pericardial effusion |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
1/31 (3.23%) |
0/40 (0.00%) |
0/38 (0.00%) |
1/39 (2.56%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
1/52 (1.92%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Endocrine disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Adrenal insufficiency |
0/12 (0.00%) |
1/16 (6.25%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
2/31 (6.45%) |
3/40 (7.50%) |
1/38 (2.63%) |
2/39 (5.13%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
1/52 (1.92%) |
1/9 (11.11%) |
0/15 (0.00%) |
0/9 (0.00%) |
Hyperthyroidism |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
1/40 (2.50%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
1/52 (1.92%) |
1/9 (11.11%) |
0/15 (0.00%) |
0/9 (0.00%) |
Hypophysitis |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
2/31 (6.45%) |
1/40 (2.50%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Hypopituitarism |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
1/31 (3.23%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Secondary adrenocortical insufficiency |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
1/38 (2.63%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Eye disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Blindness unilateral |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
1/39 (2.56%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Uveitis |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
1/29 (3.45%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Vitreous haemorrhage |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
1/29 (3.45%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Gastrointestinal disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Abdominal pain |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
1/40 (2.50%) |
0/38 (0.00%) |
1/39 (2.56%) |
1/15 (6.67%) |
2/29 (6.90%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Ascites |
0/12 (0.00%) |
1/16 (6.25%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Colitis |
0/12 (0.00%) |
2/16 (12.50%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
2/38 (5.26%) |
3/39 (7.69%) |
0/15 (0.00%) |
1/29 (3.45%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
1/15 (6.67%) |
1/9 (11.11%) |
Colitis ulcerative |
0/12 (0.00%) |
1/16 (6.25%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Diarrhoea |
1/12 (8.33%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
1/31 (3.23%) |
2/40 (5.00%) |
3/38 (7.89%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
1/21 (4.76%) |
1/52 (1.92%) |
1/9 (11.11%) |
1/15 (6.67%) |
0/9 (0.00%) |
Dysphagia |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
2/39 (5.13%) |
1/15 (6.67%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Gastrointestinal haemorrhage |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
1/38 (2.63%) |
0/39 (0.00%) |
0/15 (0.00%) |
1/29 (3.45%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Impaired gastric emptying |
0/12 (0.00%) |
1/16 (6.25%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Intestinal perforation |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
1/38 (2.63%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Large intestinal haemorrhage |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
1/38 (2.63%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Nausea |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
1/40 (2.50%) |
2/38 (5.26%) |
1/39 (2.56%) |
0/15 (0.00%) |
1/29 (3.45%) |
0/12 (0.00%) |
0/21 (0.00%) |
1/52 (1.92%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Oesophageal fistula |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
1/39 (2.56%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Pancreatitis |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
1/38 (2.63%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Small intestinal haemorrhage |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
1/52 (1.92%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Small intestinal obstruction |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
1/21 (4.76%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Tongue discolouration |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
1/15 (6.67%) |
0/9 (0.00%) |
Vomiting |
0/12 (0.00%) |
1/16 (6.25%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
1/40 (2.50%) |
1/38 (2.63%) |
1/39 (2.56%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
1/52 (1.92%) |
0/9 (0.00%) |
1/15 (6.67%) |
0/9 (0.00%) |
General disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Asthenia |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
1/38 (2.63%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Chest pain |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
1/12 (8.33%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
1/39 (2.56%) |
0/15 (0.00%) |
1/29 (3.45%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Disease progression |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
1/12 (8.33%) |
1/31 (3.23%) |
0/40 (0.00%) |
1/38 (2.63%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
1/9 (11.11%) |
Fatigue |
0/12 (0.00%) |
2/16 (12.50%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
1/38 (2.63%) |
1/39 (2.56%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Influenza like illness |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
1/29 (3.45%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Pain |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
1/31 (3.23%) |
0/40 (0.00%) |
2/38 (5.26%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
1/21 (4.76%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Pyrexia |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
1/13 (7.69%) |
0/12 (0.00%) |
0/31 (0.00%) |
1/40 (2.50%) |
1/38 (2.63%) |
2/39 (5.13%) |
2/15 (13.33%) |
1/29 (3.45%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Hepatobiliary disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Autoimmune hepatitis |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
1/31 (3.23%) |
3/40 (7.50%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Bile duct stenosis |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
1/38 (2.63%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Cholangitis |
0/12 (0.00%) |
0/16 (0.00%) |
1/13 (7.69%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Immune system disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hypersensitivity |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
1/15 (6.67%) |
1/29 (3.45%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Infections and infestations |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Bronchitis |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
1/39 (2.56%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Cystitis |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
1/31 (3.23%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Device related infection |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
1/21 (4.76%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Influenza |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
1/38 (2.63%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Lung infection |
0/12 (0.00%) |
2/16 (12.50%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
2/40 (5.00%) |
1/38 (2.63%) |
0/39 (0.00%) |
1/15 (6.67%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
3/52 (5.77%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Meningitis |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
1/15 (6.67%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Pneumonia |
1/12 (8.33%) |
1/16 (6.25%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
3/31 (9.68%) |
1/40 (2.50%) |
2/38 (5.26%) |
1/39 (2.56%) |
1/15 (6.67%) |
1/29 (3.45%) |
0/12 (0.00%) |
1/21 (4.76%) |
1/52 (1.92%) |
2/9 (22.22%) |
2/15 (13.33%) |
0/9 (0.00%) |
Sepsis |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
1/52 (1.92%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Skin infection |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
1/31 (3.23%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Upper respiratory tract infection |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
1/21 (4.76%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Urinary tract infection |
0/12 (0.00%) |
1/16 (6.25%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
1/38 (2.63%) |
0/39 (0.00%) |
0/15 (0.00%) |
1/29 (3.45%) |
1/12 (8.33%) |
1/21 (4.76%) |
1/52 (1.92%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Injury, poisoning and procedural complications |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fall |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
1/40 (2.50%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
2/21 (9.52%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Hip fracture |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
1/38 (2.63%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Humerus fracture |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
1/39 (2.56%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Infusion related reaction |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
1/52 (1.92%) |
0/9 (0.00%) |
0/15 (0.00%) |
1/9 (11.11%) |
Lumbar vertebral fracture |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
1/40 (2.50%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Radiation necrosis |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
1/40 (2.50%) |
1/38 (2.63%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Spinal compression fracture |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
1/40 (2.50%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Investigations |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Alanine aminotransferase increased |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
1/31 (3.23%) |
1/40 (2.50%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
1/21 (4.76%) |
1/52 (1.92%) |
0/9 (0.00%) |
2/15 (13.33%) |
0/9 (0.00%) |
Amylase increased |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
1/15 (6.67%) |
0/9 (0.00%) |
Aspartate aminotransferase increased |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
1/31 (3.23%) |
1/40 (2.50%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
1/21 (4.76%) |
1/52 (1.92%) |
0/9 (0.00%) |
2/15 (13.33%) |
0/9 (0.00%) |
Blood bilirubin increased |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
1/31 (3.23%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
1/21 (4.76%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Blood creatinine increased |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
1/38 (2.63%) |
0/39 (0.00%) |
1/15 (6.67%) |
1/29 (3.45%) |
0/12 (0.00%) |
1/21 (4.76%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
International normalised ratio increased |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
1/38 (2.63%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Lipase increased |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
1/29 (3.45%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
1/15 (6.67%) |
0/9 (0.00%) |
Neutrophil count decreased |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
1/29 (3.45%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Platelet count decreased |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
1/15 (6.67%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Transaminases increased |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
1/39 (2.56%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Metabolism and nutrition disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dehydration |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
1/12 (8.33%) |
1/31 (3.23%) |
1/40 (2.50%) |
1/38 (2.63%) |
4/39 (10.26%) |
0/15 (0.00%) |
1/29 (3.45%) |
1/12 (8.33%) |
1/21 (4.76%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Diabetes mellitus |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
1/40 (2.50%) |
0/38 (0.00%) |
1/39 (2.56%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
1/52 (1.92%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Hypercalcaemia |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
1/9 (11.11%) |
0/15 (0.00%) |
0/9 (0.00%) |
Hypoglycaemia |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
1/21 (4.76%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Hypokalaemia |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
1/38 (2.63%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Hyponatraemia |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
1/31 (3.23%) |
1/40 (2.50%) |
0/38 (0.00%) |
1/39 (2.56%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
1/9 (11.11%) |
0/15 (0.00%) |
0/9 (0.00%) |
Latent autoimmune diabetes in adults |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
1/15 (6.67%) |
0/9 (0.00%) |
Type 1 diabetes mellitus |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
1/38 (2.63%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Musculoskeletal and connective tissue disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Arthritis |
0/12 (0.00%) |
0/16 (0.00%) |
1/13 (7.69%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
1/15 (6.67%) |
0/9 (0.00%) |
Back pain |
0/12 (0.00%) |
1/16 (6.25%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
1/31 (3.23%) |
2/40 (5.00%) |
0/38 (0.00%) |
1/39 (2.56%) |
0/15 (0.00%) |
2/29 (6.90%) |
0/12 (0.00%) |
0/21 (0.00%) |
1/52 (1.92%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Bone pain |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
1/12 (8.33%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Muscular weakness |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
1/31 (3.23%) |
1/40 (2.50%) |
0/38 (0.00%) |
1/39 (2.56%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Musculoskeletal pain |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
1/39 (2.56%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Myositis |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
1/40 (2.50%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Pathological fracture |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
1/52 (1.92%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basal cell carcinoma |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
1/21 (4.76%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Cancer pain |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
1/9 (11.11%) |
Malignant neoplasm progression |
0/12 (0.00%) |
1/16 (6.25%) |
0/13 (0.00%) |
1/13 (7.69%) |
0/12 (0.00%) |
0/31 (0.00%) |
1/40 (2.50%) |
0/38 (0.00%) |
2/39 (5.13%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
1/21 (4.76%) |
1/52 (1.92%) |
2/9 (22.22%) |
1/15 (6.67%) |
0/9 (0.00%) |
Skin cancer |
0/12 (0.00%) |
0/16 (0.00%) |
1/13 (7.69%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Squamous cell carcinoma of skin |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
1/21 (4.76%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Transitional cell carcinoma |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
1/38 (2.63%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Tumour pain |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
1/12 (8.33%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Nervous system disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Brain oedema |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
1/12 (8.33%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Cerebrovascular accident |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
1/40 (2.50%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
1/29 (3.45%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Cognitive disorder |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
1/15 (6.67%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Embolic cerebral infarction |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
1/40 (2.50%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Encephalopathy |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
1/39 (2.56%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Facial nerve disorder |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
1/39 (2.56%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Headache |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
1/15 (6.67%) |
1/29 (3.45%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
1/15 (6.67%) |
0/9 (0.00%) |
Miller fisher syndrome |
0/12 (0.00%) |
1/16 (6.25%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Nervous system disorder |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
1/12 (8.33%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Paraesthesia |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
1/29 (3.45%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Peripheral motor neuropathy |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
1/39 (2.56%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Seizure |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
1/12 (8.33%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
1/52 (1.92%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Spinal cord compression |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
1/21 (4.76%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Syncope |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
2/15 (13.33%) |
1/29 (3.45%) |
0/12 (0.00%) |
0/21 (0.00%) |
1/52 (1.92%) |
0/9 (0.00%) |
1/15 (6.67%) |
0/9 (0.00%) |
Vocal cord paralysis |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
1/52 (1.92%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Psychiatric disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Anxiety |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
1/39 (2.56%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Confusional state |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
1/31 (3.23%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
1/15 (6.67%) |
0/29 (0.00%) |
1/12 (8.33%) |
0/21 (0.00%) |
2/52 (3.85%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Delirium |
0/12 (0.00%) |
1/16 (6.25%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
1/38 (2.63%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Mental status changes |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
1/40 (2.50%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Renal and urinary disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Acute kidney injury |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
1/40 (2.50%) |
2/38 (5.26%) |
0/39 (0.00%) |
1/15 (6.67%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Nephritis allergic |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
1/29 (3.45%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
1/15 (6.67%) |
0/9 (0.00%) |
Renal salt-wasting syndrome |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
1/15 (6.67%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Tubulointerstitial nephritis |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
1/12 (8.33%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Respiratory, thoracic and mediastinal disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Acute respiratory failure |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
1/38 (2.63%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Bronchial obstruction |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
1/52 (1.92%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Chronic obstructive pulmonary disease |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
1/38 (2.63%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
2/52 (3.85%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Cough |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
1/12 (8.33%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
1/39 (2.56%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Dyspnoea |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
2/31 (6.45%) |
2/40 (5.00%) |
3/38 (7.89%) |
4/39 (10.26%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
1/21 (4.76%) |
1/52 (1.92%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Haemoptysis |
1/12 (8.33%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
1/39 (2.56%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Pleural effusion |
0/12 (0.00%) |
2/16 (12.50%) |
0/13 (0.00%) |
2/13 (15.38%) |
0/12 (0.00%) |
2/31 (6.45%) |
2/40 (5.00%) |
2/38 (5.26%) |
1/39 (2.56%) |
1/15 (6.67%) |
1/29 (3.45%) |
0/12 (0.00%) |
1/21 (4.76%) |
2/52 (3.85%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Pneumonitis |
2/12 (16.67%) |
1/16 (6.25%) |
0/13 (0.00%) |
2/13 (15.38%) |
0/12 (0.00%) |
2/31 (6.45%) |
2/40 (5.00%) |
2/38 (5.26%) |
1/39 (2.56%) |
1/15 (6.67%) |
1/29 (3.45%) |
0/12 (0.00%) |
0/21 (0.00%) |
1/52 (1.92%) |
2/9 (22.22%) |
1/15 (6.67%) |
1/9 (11.11%) |
Pneumothorax |
1/12 (8.33%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
1/52 (1.92%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Pulmonary embolism |
0/12 (0.00%) |
2/16 (12.50%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
1/38 (2.63%) |
1/39 (2.56%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
1/52 (1.92%) |
0/9 (0.00%) |
1/15 (6.67%) |
0/9 (0.00%) |
Pulmonary haemorrhage |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
1/40 (2.50%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
1/9 (11.11%) |
Respiratory acidosis |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
1/38 (2.63%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Respiratory distress |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
1/39 (2.56%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Respiratory failure |
0/12 (0.00%) |
1/16 (6.25%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
1/38 (2.63%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
1/9 (11.11%) |
1/15 (6.67%) |
0/9 (0.00%) |
Skin and subcutaneous tissue disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Petechiae |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
1/38 (2.63%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Pruritus |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
1/29 (3.45%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Rash |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
1/31 (3.23%) |
1/40 (2.50%) |
1/38 (2.63%) |
1/39 (2.56%) |
0/15 (0.00%) |
1/29 (3.45%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Rash maculo-papular |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
2/29 (6.90%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Vascular disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Aortic stenosis |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
1/52 (1.92%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Embolism |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
1/40 (2.50%) |
1/38 (2.63%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
2/15 (13.33%) |
0/9 (0.00%) |
Haematoma |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
1/29 (3.45%) |
0/12 (0.00%) |
1/21 (4.76%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Hypertension |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
1/40 (2.50%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Hypotension |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
1/40 (2.50%) |
2/38 (5.26%) |
0/39 (0.00%) |
2/15 (13.33%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
1/52 (1.92%) |
0/9 (0.00%) |
1/15 (6.67%) |
0/9 (0.00%) |
Superior vena cava syndrome |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
1/21 (4.76%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Thrombosis |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
1/39 (2.56%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Indicates events were collected by systematic assessment
Term from vocabulary, MedDRA 19.0
|
|
Frequency Threshold for Reporting Other Adverse Events
|
5%
|
|
Arm A: Nivolumab + Gemcitabine + Cisplatin
|
Arm J: Nivolumab + Ipilimumab
|
Arm K: Nivolumab In Squamous Histology Subjects (NSCLC)
|
Arm L: Nivolumab In Non-squamous Histology Subjects (NSCLC)
|
Arm M: Nivolumab
|
Arm N: Nivolumab + Ipilimumab
|
Arm O: Nivolumab + Ipilimumab
|
Arm P: Nivolumab + Ipilimumab
|
Arm Q: Nivolumab + Ipilimumab
|
Arm B: Nivolumab + Pemetrexed + Cisplatin
|
Arm C: Nivolumab + Paclitaxel + Carboplatin
|
Arm D: Nivolumab + Bevacizumab Maintenance
|
Arm E: Nivolumab + Erlotinib
|
Arm F: Nivolumab
|
Arm G: Nivolumab + Ipilimumab
|
Arm H: Nivolumab + Ipilimumab
|
Arm I: Nivolumab + Ipilimumab
|
|
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Total |
12/12 (100.00%) |
16/16 (100.00%) |
11/13 (84.62%) |
13/13 (100.00%) |
11/12 (91.67%) |
30/31 (96.77%) |
33/40 (82.50%) |
35/38 (92.11%) |
33/39 (84.62%) |
15/15 (100.00%) |
29/29 (100.00%) |
11/12 (91.67%) |
21/21 (100.00%) |
50/52 (96.15%) |
9/9 (100.00%) |
15/15 (100.00%) |
9/9 (100.00%) |
Blood and lymphatic system disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Anaemia |
8/12 (66.67%) |
1/16 (6.25%) |
1/13 (7.69%) |
0/13 (0.00%) |
0/12 (0.00%) |
4/31 (12.90%) |
5/40 (12.50%) |
6/38 (15.79%) |
5/39 (12.82%) |
2/15 (13.33%) |
8/29 (27.59%) |
0/12 (0.00%) |
0/21 (0.00%) |
2/52 (3.85%) |
1/9 (11.11%) |
1/15 (6.67%) |
2/9 (22.22%) |
Granulocytopenia |
1/12 (8.33%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Leukopenia |
1/12 (8.33%) |
0/16 (0.00%) |
1/13 (7.69%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
2/15 (13.33%) |
3/29 (10.34%) |
0/12 (0.00%) |
0/21 (0.00%) |
1/52 (1.92%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Lymphadenitis |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
1/15 (6.67%) |
0/9 (0.00%) |
Lymphadenopathy |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
1/13 (7.69%) |
0/12 (0.00%) |
0/31 (0.00%) |
1/40 (2.50%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Lymphopenia |
1/12 (8.33%) |
2/16 (12.50%) |
0/13 (0.00%) |
1/13 (7.69%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
1/15 (6.67%) |
4/29 (13.79%) |
0/12 (0.00%) |
0/21 (0.00%) |
1/52 (1.92%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Neutropenia |
2/12 (16.67%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
1/15 (6.67%) |
3/29 (10.34%) |
0/12 (0.00%) |
1/21 (4.76%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Polycythaemia |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
1/15 (6.67%) |
0/9 (0.00%) |
Thrombocytopenia |
3/12 (25.00%) |
1/16 (6.25%) |
0/13 (0.00%) |
1/13 (7.69%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
1/29 (3.45%) |
0/12 (0.00%) |
0/21 (0.00%) |
1/52 (1.92%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Cardiac disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Angina pectoris |
1/12 (8.33%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Atrial fibrillation |
1/12 (8.33%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
1/40 (2.50%) |
1/38 (2.63%) |
2/39 (5.13%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
1/52 (1.92%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Atrial flutter |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
1/9 (11.11%) |
0/15 (0.00%) |
0/9 (0.00%) |
Palpitations |
1/12 (8.33%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
3/29 (10.34%) |
0/12 (0.00%) |
0/21 (0.00%) |
1/52 (1.92%) |
0/9 (0.00%) |
1/15 (6.67%) |
0/9 (0.00%) |
Pericardial effusion |
0/12 (0.00%) |
1/16 (6.25%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
1/39 (2.56%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Sinus tachycardia |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
1/39 (2.56%) |
0/15 (0.00%) |
1/29 (3.45%) |
0/12 (0.00%) |
1/21 (4.76%) |
0/52 (0.00%) |
0/9 (0.00%) |
2/15 (13.33%) |
0/9 (0.00%) |
Supraventricular tachycardia |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
1/15 (6.67%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Tachycardia |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
1/12 (8.33%) |
0/31 (0.00%) |
1/40 (2.50%) |
2/38 (5.26%) |
1/39 (2.56%) |
1/15 (6.67%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
1/52 (1.92%) |
0/9 (0.00%) |
1/15 (6.67%) |
0/9 (0.00%) |
Ear and labyrinth disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deafness |
1/12 (8.33%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
1/38 (2.63%) |
0/39 (0.00%) |
2/15 (13.33%) |
1/29 (3.45%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Deafness unilateral |
0/12 (0.00%) |
0/16 (0.00%) |
1/13 (7.69%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Ear discomfort |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
1/40 (2.50%) |
2/38 (5.26%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
1/52 (1.92%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Ear pain |
1/12 (8.33%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
3/40 (7.50%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
1/29 (3.45%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Hypoacusis |
1/12 (8.33%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
1/21 (4.76%) |
1/52 (1.92%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Tinnitus |
1/12 (8.33%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
1/38 (2.63%) |
0/39 (0.00%) |
5/15 (33.33%) |
0/29 (0.00%) |
1/12 (8.33%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Vertigo |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
1/40 (2.50%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
1/12 (8.33%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Endocrine disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Adrenal insufficiency |
0/12 (0.00%) |
1/16 (6.25%) |
0/13 (0.00%) |
1/13 (7.69%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
1/38 (2.63%) |
4/39 (10.26%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
1/15 (6.67%) |
0/9 (0.00%) |
Autoimmune thyroiditis |
0/12 (0.00%) |
1/16 (6.25%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
1/40 (2.50%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
1/21 (4.76%) |
0/52 (0.00%) |
0/9 (0.00%) |
2/15 (13.33%) |
0/9 (0.00%) |
Hyperthyroidism |
1/12 (8.33%) |
2/16 (12.50%) |
0/13 (0.00%) |
0/13 (0.00%) |
1/12 (8.33%) |
2/31 (6.45%) |
2/40 (5.00%) |
2/38 (5.26%) |
4/39 (10.26%) |
0/15 (0.00%) |
0/29 (0.00%) |
1/12 (8.33%) |
2/21 (9.52%) |
0/52 (0.00%) |
1/9 (11.11%) |
1/15 (6.67%) |
0/9 (0.00%) |
Hypophysitis |
0/12 (0.00%) |
1/16 (6.25%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
1/31 (3.23%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
1/9 (11.11%) |
0/15 (0.00%) |
1/9 (11.11%) |
Hypothyroidism |
1/12 (8.33%) |
1/16 (6.25%) |
2/13 (15.38%) |
1/13 (7.69%) |
0/12 (0.00%) |
2/31 (6.45%) |
6/40 (15.00%) |
4/38 (10.53%) |
5/39 (12.82%) |
1/15 (6.67%) |
1/29 (3.45%) |
1/12 (8.33%) |
3/21 (14.29%) |
4/52 (7.69%) |
1/9 (11.11%) |
2/15 (13.33%) |
1/9 (11.11%) |
Thyroiditis |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
1/12 (8.33%) |
0/21 (0.00%) |
2/52 (3.85%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Eye disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Astigmatism |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
1/12 (8.33%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Cataract |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
1/12 (8.33%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
1/39 (2.56%) |
0/15 (0.00%) |
2/29 (6.90%) |
0/12 (0.00%) |
1/21 (4.76%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Chalazion |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
1/15 (6.67%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Diplopia |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
2/12 (16.67%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
1/39 (2.56%) |
0/15 (0.00%) |
1/29 (3.45%) |
0/12 (0.00%) |
0/21 (0.00%) |
1/52 (1.92%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Dry eye |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
2/38 (5.26%) |
3/39 (7.69%) |
2/15 (13.33%) |
2/29 (6.90%) |
1/12 (8.33%) |
1/21 (4.76%) |
1/52 (1.92%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Eye discharge |
0/12 (0.00%) |
1/16 (6.25%) |
0/13 (0.00%) |
0/13 (0.00%) |
1/12 (8.33%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
1/15 (6.67%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
1/52 (1.92%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Eye irritation |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
1/38 (2.63%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
3/21 (14.29%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Eye pruritus |
0/12 (0.00%) |
1/16 (6.25%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
1/21 (4.76%) |
1/52 (1.92%) |
0/9 (0.00%) |
1/15 (6.67%) |
0/9 (0.00%) |
Eye swelling |
0/12 (0.00%) |
1/16 (6.25%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
1/40 (2.50%) |
0/38 (0.00%) |
0/39 (0.00%) |
1/15 (6.67%) |
1/29 (3.45%) |
0/12 (0.00%) |
1/21 (4.76%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Eyelid oedema |
1/12 (8.33%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Lacrimation increased |
0/12 (0.00%) |
1/16 (6.25%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
1/38 (2.63%) |
0/39 (0.00%) |
2/15 (13.33%) |
0/29 (0.00%) |
1/12 (8.33%) |
2/21 (9.52%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Ocular hyperaemia |
0/12 (0.00%) |
1/16 (6.25%) |
0/13 (0.00%) |
0/13 (0.00%) |
1/12 (8.33%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
1/12 (8.33%) |
0/21 (0.00%) |
1/52 (1.92%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Periorbital oedema |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
1/31 (3.23%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
2/21 (9.52%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Vision blurred |
0/12 (0.00%) |
0/16 (0.00%) |
1/13 (7.69%) |
0/13 (0.00%) |
1/12 (8.33%) |
0/31 (0.00%) |
1/40 (2.50%) |
1/38 (2.63%) |
2/39 (5.13%) |
2/15 (13.33%) |
5/29 (17.24%) |
0/12 (0.00%) |
2/21 (9.52%) |
1/52 (1.92%) |
0/9 (0.00%) |
1/15 (6.67%) |
0/9 (0.00%) |
Visual impairment |
0/12 (0.00%) |
1/16 (6.25%) |
0/13 (0.00%) |
0/13 (0.00%) |
1/12 (8.33%) |
0/31 (0.00%) |
0/40 (0.00%) |
1/38 (2.63%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
1/21 (4.76%) |
3/52 (5.77%) |
0/9 (0.00%) |
1/15 (6.67%) |
1/9 (11.11%) |
Vitreous floaters |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
1/31 (3.23%) |
1/40 (2.50%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
1/29 (3.45%) |
1/12 (8.33%) |
1/21 (4.76%) |
1/52 (1.92%) |
0/9 (0.00%) |
1/15 (6.67%) |
0/9 (0.00%) |
Gastrointestinal disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Abdominal discomfort |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
2/40 (5.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
2/52 (3.85%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Abdominal distension |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
1/31 (3.23%) |
1/40 (2.50%) |
1/38 (2.63%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
1/12 (8.33%) |
1/21 (4.76%) |
2/52 (3.85%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Abdominal pain |
0/12 (0.00%) |
2/16 (12.50%) |
2/13 (15.38%) |
1/13 (7.69%) |
2/12 (16.67%) |
3/31 (9.68%) |
3/40 (7.50%) |
4/38 (10.53%) |
4/39 (10.26%) |
1/15 (6.67%) |
2/29 (6.90%) |
1/12 (8.33%) |
2/21 (9.52%) |
5/52 (9.62%) |
0/9 (0.00%) |
2/15 (13.33%) |
0/9 (0.00%) |
Abdominal pain lower |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
1/40 (2.50%) |
1/38 (2.63%) |
0/39 (0.00%) |
0/15 (0.00%) |
2/29 (6.90%) |
0/12 (0.00%) |
1/21 (4.76%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Abdominal pain upper |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
1/12 (8.33%) |
2/31 (6.45%) |
1/40 (2.50%) |
6/38 (15.79%) |
1/39 (2.56%) |
0/15 (0.00%) |
0/29 (0.00%) |
1/12 (8.33%) |
1/21 (4.76%) |
4/52 (7.69%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Anogenital dysplasia |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
1/12 (8.33%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Ascites |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
1/31 (3.23%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
1/15 (6.67%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Colitis |
0/12 (0.00%) |
1/16 (6.25%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
1/31 (3.23%) |
0/40 (0.00%) |
0/38 (0.00%) |
3/39 (7.69%) |
1/15 (6.67%) |
1/29 (3.45%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Constipation |
10/12 (83.33%) |
6/16 (37.50%) |
0/13 (0.00%) |
1/13 (7.69%) |
3/12 (25.00%) |
6/31 (19.35%) |
11/40 (27.50%) |
8/38 (21.05%) |
10/39 (25.64%) |
6/15 (40.00%) |
15/29 (51.72%) |
1/12 (8.33%) |
9/21 (42.86%) |
17/52 (32.69%) |
2/9 (22.22%) |
3/15 (20.00%) |
1/9 (11.11%) |
Defaecation urgency |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
1/9 (11.11%) |
Dental caries |
0/12 (0.00%) |
1/16 (6.25%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Diarrhoea |
3/12 (25.00%) |
6/16 (37.50%) |
5/13 (38.46%) |
1/13 (7.69%) |
1/12 (8.33%) |
11/31 (35.48%) |
13/40 (32.50%) |
10/38 (26.32%) |
12/39 (30.77%) |
5/15 (33.33%) |
14/29 (48.28%) |
2/12 (16.67%) |
10/21 (47.62%) |
15/52 (28.85%) |
4/9 (44.44%) |
10/15 (66.67%) |
2/9 (22.22%) |
Dry mouth |
1/12 (8.33%) |
3/16 (18.75%) |
1/13 (7.69%) |
1/13 (7.69%) |
0/12 (0.00%) |
5/31 (16.13%) |
5/40 (12.50%) |
3/38 (7.89%) |
4/39 (10.26%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
5/21 (23.81%) |
5/52 (9.62%) |
0/9 (0.00%) |
1/15 (6.67%) |
1/9 (11.11%) |
Dyspepsia |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
2/13 (15.38%) |
0/12 (0.00%) |
0/31 (0.00%) |
4/40 (10.00%) |
2/38 (5.26%) |
3/39 (7.69%) |
2/15 (13.33%) |
2/29 (6.90%) |
0/12 (0.00%) |
1/21 (4.76%) |
1/52 (1.92%) |
1/9 (11.11%) |
0/15 (0.00%) |
0/9 (0.00%) |
Dysphagia |
1/12 (8.33%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
1/12 (8.33%) |
1/31 (3.23%) |
0/40 (0.00%) |
3/38 (7.89%) |
2/39 (5.13%) |
1/15 (6.67%) |
2/29 (6.90%) |
0/12 (0.00%) |
0/21 (0.00%) |
1/52 (1.92%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Enterocolitis |
0/12 (0.00%) |
1/16 (6.25%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Eructation |
1/12 (8.33%) |
1/16 (6.25%) |
0/13 (0.00%) |
1/13 (7.69%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
1/9 (11.11%) |
0/15 (0.00%) |
0/9 (0.00%) |
Flatulence |
0/12 (0.00%) |
1/16 (6.25%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
2/38 (5.26%) |
1/39 (2.56%) |
0/15 (0.00%) |
2/29 (6.90%) |
0/12 (0.00%) |
0/21 (0.00%) |
1/52 (1.92%) |
0/9 (0.00%) |
0/15 (0.00%) |
2/9 (22.22%) |
Gastric disorder |
0/12 (0.00%) |
0/16 (0.00%) |
1/13 (7.69%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Gastritis |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
1/13 (7.69%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
1/39 (2.56%) |
1/15 (6.67%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Gastrooesophageal reflux disease |
1/12 (8.33%) |
1/16 (6.25%) |
0/13 (0.00%) |
1/13 (7.69%) |
0/12 (0.00%) |
3/31 (9.68%) |
2/40 (5.00%) |
2/38 (5.26%) |
2/39 (5.13%) |
1/15 (6.67%) |
2/29 (6.90%) |
0/12 (0.00%) |
1/21 (4.76%) |
0/52 (0.00%) |
1/9 (11.11%) |
0/15 (0.00%) |
0/9 (0.00%) |
Gingival bleeding |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
1/40 (2.50%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
1/12 (8.33%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Gingival pain |
0/12 (0.00%) |
1/16 (6.25%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
1/39 (2.56%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
1/52 (1.92%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Glossodynia |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
1/13 (7.69%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Haematochezia |
0/12 (0.00%) |
1/16 (6.25%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
1/38 (2.63%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
1/9 (11.11%) |
Haemorrhoidal haemorrhage |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
1/13 (7.69%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Mouth ulceration |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
1/12 (8.33%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Nausea |
8/12 (66.67%) |
8/16 (50.00%) |
2/13 (15.38%) |
0/13 (0.00%) |
2/12 (16.67%) |
9/31 (29.03%) |
12/40 (30.00%) |
10/38 (26.32%) |
11/39 (28.21%) |
12/15 (80.00%) |
12/29 (41.38%) |
3/12 (25.00%) |
10/21 (47.62%) |
17/52 (32.69%) |
2/9 (22.22%) |
6/15 (40.00%) |
3/9 (33.33%) |
Oral pain |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
1/31 (3.23%) |
2/40 (5.00%) |
0/38 (0.00%) |
1/39 (2.56%) |
0/15 (0.00%) |
0/29 (0.00%) |
1/12 (8.33%) |
0/21 (0.00%) |
1/52 (1.92%) |
0/9 (0.00%) |
1/15 (6.67%) |
0/9 (0.00%) |
Pancreatitis |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
1/12 (8.33%) |
0/31 (0.00%) |
0/40 (0.00%) |
1/38 (2.63%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Periodontal disease |
0/12 (0.00%) |
0/16 (0.00%) |
1/13 (7.69%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Salivary hypersecretion |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
1/15 (6.67%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Sensitivity of teeth |
0/12 (0.00%) |
1/16 (6.25%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Steatorrhoea |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
1/12 (8.33%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Stomatitis |
1/12 (8.33%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
2/40 (5.00%) |
0/38 (0.00%) |
2/39 (5.13%) |
0/15 (0.00%) |
3/29 (10.34%) |
0/12 (0.00%) |
2/21 (9.52%) |
1/52 (1.92%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Toothache |
1/12 (8.33%) |
0/16 (0.00%) |
1/13 (7.69%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
1/12 (8.33%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Vomiting |
2/12 (16.67%) |
7/16 (43.75%) |
0/13 (0.00%) |
0/13 (0.00%) |
2/12 (16.67%) |
2/31 (6.45%) |
8/40 (20.00%) |
5/38 (13.16%) |
5/39 (12.82%) |
6/15 (40.00%) |
9/29 (31.03%) |
1/12 (8.33%) |
7/21 (33.33%) |
7/52 (13.46%) |
2/9 (22.22%) |
2/15 (13.33%) |
1/9 (11.11%) |
General disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Asthenia |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
1/13 (7.69%) |
0/12 (0.00%) |
0/31 (0.00%) |
1/40 (2.50%) |
2/38 (5.26%) |
2/39 (5.13%) |
2/15 (13.33%) |
0/29 (0.00%) |
1/12 (8.33%) |
1/21 (4.76%) |
1/52 (1.92%) |
1/9 (11.11%) |
0/15 (0.00%) |
0/9 (0.00%) |
Catheter site erythema |
0/12 (0.00%) |
1/16 (6.25%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Catheter site pruritus |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
1/12 (8.33%) |
0/31 (0.00%) |
1/40 (2.50%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Chest discomfort |
1/12 (8.33%) |
1/16 (6.25%) |
0/13 (0.00%) |
1/13 (7.69%) |
1/12 (8.33%) |
1/31 (3.23%) |
1/40 (2.50%) |
0/38 (0.00%) |
1/39 (2.56%) |
1/15 (6.67%) |
0/29 (0.00%) |
1/12 (8.33%) |
0/21 (0.00%) |
1/52 (1.92%) |
0/9 (0.00%) |
0/15 (0.00%) |
1/9 (11.11%) |
Chest pain |
2/12 (16.67%) |
1/16 (6.25%) |
0/13 (0.00%) |
1/13 (7.69%) |
0/12 (0.00%) |
2/31 (6.45%) |
2/40 (5.00%) |
1/38 (2.63%) |
3/39 (7.69%) |
1/15 (6.67%) |
2/29 (6.90%) |
1/12 (8.33%) |
2/21 (9.52%) |
1/52 (1.92%) |
0/9 (0.00%) |
1/15 (6.67%) |
0/9 (0.00%) |
Chills |
1/12 (8.33%) |
2/16 (12.50%) |
2/13 (15.38%) |
0/13 (0.00%) |
1/12 (8.33%) |
3/31 (9.68%) |
1/40 (2.50%) |
5/38 (13.16%) |
5/39 (12.82%) |
1/15 (6.67%) |
1/29 (3.45%) |
1/12 (8.33%) |
1/21 (4.76%) |
2/52 (3.85%) |
1/9 (11.11%) |
4/15 (26.67%) |
0/9 (0.00%) |
Decreased activity |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
1/15 (6.67%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Energy increased |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
1/13 (7.69%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
1/29 (3.45%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Face oedema |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
1/38 (2.63%) |
0/39 (0.00%) |
1/15 (6.67%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Fatigue |
10/12 (83.33%) |
11/16 (68.75%) |
6/13 (46.15%) |
7/13 (53.85%) |
7/12 (58.33%) |
16/31 (51.61%) |
13/40 (32.50%) |
14/38 (36.84%) |
18/39 (46.15%) |
14/15 (93.33%) |
23/29 (79.31%) |
6/12 (50.00%) |
16/21 (76.19%) |
28/52 (53.85%) |
4/9 (44.44%) |
11/15 (73.33%) |
6/9 (66.67%) |
Feeling cold |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
1/39 (2.56%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
1/21 (4.76%) |
0/52 (0.00%) |
0/9 (0.00%) |
1/15 (6.67%) |
0/9 (0.00%) |
Feeling hot |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
1/12 (8.33%) |
1/31 (3.23%) |
0/40 (0.00%) |
0/38 (0.00%) |
1/39 (2.56%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Gait disturbance |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
2/31 (6.45%) |
1/40 (2.50%) |
0/38 (0.00%) |
1/39 (2.56%) |
0/15 (0.00%) |
2/29 (6.90%) |
0/12 (0.00%) |
2/21 (9.52%) |
1/52 (1.92%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Gastrointestinal disorder |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
1/15 (6.67%) |
0/9 (0.00%) |
Implant site oedema |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
1/12 (8.33%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Inflammation |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
1/15 (6.67%) |
0/9 (0.00%) |
Influenza like illness |
0/12 (0.00%) |
2/16 (12.50%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
3/31 (9.68%) |
3/40 (7.50%) |
1/38 (2.63%) |
2/39 (5.13%) |
1/15 (6.67%) |
3/29 (10.34%) |
1/12 (8.33%) |
0/21 (0.00%) |
1/52 (1.92%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Infusion site irritation |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
1/15 (6.67%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Injection site reaction |
1/12 (8.33%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Malaise |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
1/13 (7.69%) |
1/12 (8.33%) |
0/31 (0.00%) |
1/40 (2.50%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
1/29 (3.45%) |
1/12 (8.33%) |
1/21 (4.76%) |
2/52 (3.85%) |
0/9 (0.00%) |
1/15 (6.67%) |
0/9 (0.00%) |
Mucosal inflammation |
2/12 (16.67%) |
2/16 (12.50%) |
0/13 (0.00%) |
0/13 (0.00%) |
1/12 (8.33%) |
2/31 (6.45%) |
1/40 (2.50%) |
1/38 (2.63%) |
1/39 (2.56%) |
1/15 (6.67%) |
5/29 (17.24%) |
2/12 (16.67%) |
2/21 (9.52%) |
1/52 (1.92%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Nodule |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
1/40 (2.50%) |
0/38 (0.00%) |
0/39 (0.00%) |
1/15 (6.67%) |
1/29 (3.45%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Non-cardiac chest pain |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
1/12 (8.33%) |
4/31 (12.90%) |
1/40 (2.50%) |
0/38 (0.00%) |
1/39 (2.56%) |
1/15 (6.67%) |
1/29 (3.45%) |
0/12 (0.00%) |
1/21 (4.76%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Oedema |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
1/31 (3.23%) |
0/40 (0.00%) |
1/38 (2.63%) |
0/39 (0.00%) |
1/15 (6.67%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
1/52 (1.92%) |
0/9 (0.00%) |
0/15 (0.00%) |
1/9 (11.11%) |
Oedema peripheral |
1/12 (8.33%) |
0/16 (0.00%) |
0/13 (0.00%) |
3/13 (23.08%) |
1/12 (8.33%) |
4/31 (12.90%) |
2/40 (5.00%) |
7/38 (18.42%) |
1/39 (2.56%) |
2/15 (13.33%) |
5/29 (17.24%) |
2/12 (16.67%) |
2/21 (9.52%) |
2/52 (3.85%) |
2/9 (22.22%) |
0/15 (0.00%) |
0/9 (0.00%) |
Pain |
1/12 (8.33%) |
0/16 (0.00%) |
1/13 (7.69%) |
1/13 (7.69%) |
0/12 (0.00%) |
4/31 (12.90%) |
1/40 (2.50%) |
4/38 (10.53%) |
3/39 (7.69%) |
0/15 (0.00%) |
2/29 (6.90%) |
0/12 (0.00%) |
2/21 (9.52%) |
3/52 (5.77%) |
1/9 (11.11%) |
3/15 (20.00%) |
0/9 (0.00%) |
Peripheral swelling |
0/12 (0.00%) |
1/16 (6.25%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
1/31 (3.23%) |
0/40 (0.00%) |
1/38 (2.63%) |
1/39 (2.56%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
1/21 (4.76%) |
1/52 (1.92%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Pneumonia |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
1/9 (11.11%) |
0/15 (0.00%) |
0/9 (0.00%) |
Pyrexia |
0/12 (0.00%) |
2/16 (12.50%) |
2/13 (15.38%) |
3/13 (23.08%) |
0/12 (0.00%) |
5/31 (16.13%) |
4/40 (10.00%) |
9/38 (23.68%) |
7/39 (17.95%) |
0/15 (0.00%) |
9/29 (31.03%) |
1/12 (8.33%) |
5/21 (23.81%) |
6/52 (11.54%) |
2/9 (22.22%) |
6/15 (40.00%) |
0/9 (0.00%) |
Temperature intolerance |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
1/12 (8.33%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
1/52 (1.92%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Xerosis |
0/12 (0.00%) |
1/16 (6.25%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
1/15 (6.67%) |
0/29 (0.00%) |
0/12 (0.00%) |
2/21 (9.52%) |
2/52 (3.85%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Immune system disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Autoimmune disorder |
0/12 (0.00%) |
0/16 (0.00%) |
1/13 (7.69%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Hypersensitivity |
1/12 (8.33%) |
0/16 (0.00%) |
1/13 (7.69%) |
0/13 (0.00%) |
0/12 (0.00%) |
1/31 (3.23%) |
0/40 (0.00%) |
0/38 (0.00%) |
1/39 (2.56%) |
2/15 (13.33%) |
5/29 (17.24%) |
0/12 (0.00%) |
0/21 (0.00%) |
2/52 (3.85%) |
0/9 (0.00%) |
1/15 (6.67%) |
0/9 (0.00%) |
Seasonal allergy |
0/12 (0.00%) |
0/16 (0.00%) |
1/13 (7.69%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
1/39 (2.56%) |
0/15 (0.00%) |
1/29 (3.45%) |
0/12 (0.00%) |
1/21 (4.76%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Infections and infestations |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Alpha haemolytic streptococcal infection |
0/12 (0.00%) |
0/16 (0.00%) |
1/13 (7.69%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Angular cheilitis |
1/12 (8.33%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Body tinea |
0/12 (0.00%) |
0/16 (0.00%) |
1/13 (7.69%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Bronchiolitis |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
1/15 (6.67%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Bronchitis |
1/12 (8.33%) |
0/16 (0.00%) |
1/13 (7.69%) |
0/13 (0.00%) |
0/12 (0.00%) |
1/31 (3.23%) |
0/40 (0.00%) |
1/38 (2.63%) |
2/39 (5.13%) |
1/15 (6.67%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
2/52 (3.85%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Candida infection |
0/12 (0.00%) |
1/16 (6.25%) |
0/13 (0.00%) |
1/13 (7.69%) |
1/12 (8.33%) |
0/31 (0.00%) |
0/40 (0.00%) |
1/38 (2.63%) |
1/39 (2.56%) |
1/15 (6.67%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
1/52 (1.92%) |
0/9 (0.00%) |
1/15 (6.67%) |
0/9 (0.00%) |
Conjunctivitis |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
1/21 (4.76%) |
0/52 (0.00%) |
0/9 (0.00%) |
2/15 (13.33%) |
1/9 (11.11%) |
Cystitis |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
1/15 (6.67%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Cystitis bacterial |
0/12 (0.00%) |
0/16 (0.00%) |
1/13 (7.69%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Diverticulitis |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
2/29 (6.90%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Ear infection |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
2/15 (13.33%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Fungal infection |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
1/21 (4.76%) |
0/52 (0.00%) |
0/9 (0.00%) |
1/15 (6.67%) |
0/9 (0.00%) |
Gastroenteritis viral |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
1/40 (2.50%) |
0/38 (0.00%) |
0/39 (0.00%) |
1/15 (6.67%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Genital herpes |
0/12 (0.00%) |
1/16 (6.25%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Herpes virus infection |
0/12 (0.00%) |
1/16 (6.25%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Herpes zoster |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
3/31 (9.68%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
1/21 (4.76%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Lung infection |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
1/31 (3.23%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
1/15 (6.67%) |
1/29 (3.45%) |
1/12 (8.33%) |
1/21 (4.76%) |
1/52 (1.92%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Metapneumovirus infection |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
1/15 (6.67%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Nail infection |
0/12 (0.00%) |
1/16 (6.25%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Nasopharyngitis |
0/12 (0.00%) |
0/16 (0.00%) |
1/13 (7.69%) |
0/13 (0.00%) |
0/12 (0.00%) |
1/31 (3.23%) |
1/40 (2.50%) |
2/38 (5.26%) |
1/39 (2.56%) |
1/15 (6.67%) |
1/29 (3.45%) |
1/12 (8.33%) |
2/21 (9.52%) |
2/52 (3.85%) |
1/9 (11.11%) |
0/15 (0.00%) |
0/9 (0.00%) |
Oral candidiasis |
0/12 (0.00%) |
1/16 (6.25%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
1/31 (3.23%) |
0/40 (0.00%) |
2/38 (5.26%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
2/15 (13.33%) |
0/9 (0.00%) |
Paronychia |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
6/21 (28.57%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Pharyngitis streptococcal |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
1/12 (8.33%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
1/39 (2.56%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Pilonidal cyst |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
1/9 (11.11%) |
Pneumonia |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
1/12 (8.33%) |
0/31 (0.00%) |
2/40 (5.00%) |
1/38 (2.63%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
4/52 (7.69%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Rash pustular |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
1/31 (3.23%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
3/21 (14.29%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Respiratory tract infection |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
1/13 (7.69%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
1/21 (4.76%) |
1/52 (1.92%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Rhinitis |
0/12 (0.00%) |
1/16 (6.25%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
1/31 (3.23%) |
1/40 (2.50%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
2/52 (3.85%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Sinusitis |
1/12 (8.33%) |
1/16 (6.25%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
3/31 (9.68%) |
3/40 (7.50%) |
2/38 (5.26%) |
0/39 (0.00%) |
1/15 (6.67%) |
3/29 (10.34%) |
2/12 (16.67%) |
0/21 (0.00%) |
3/52 (5.77%) |
0/9 (0.00%) |
1/15 (6.67%) |
0/9 (0.00%) |
Skin infection |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
1/12 (8.33%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Upper respiratory tract infection |
1/12 (8.33%) |
0/16 (0.00%) |
1/13 (7.69%) |
1/13 (7.69%) |
0/12 (0.00%) |
3/31 (9.68%) |
4/40 (10.00%) |
1/38 (2.63%) |
3/39 (7.69%) |
0/15 (0.00%) |
0/29 (0.00%) |
3/12 (25.00%) |
3/21 (14.29%) |
2/52 (3.85%) |
0/9 (0.00%) |
1/15 (6.67%) |
1/9 (11.11%) |
Urinary tract infection |
1/12 (8.33%) |
1/16 (6.25%) |
1/13 (7.69%) |
0/13 (0.00%) |
1/12 (8.33%) |
2/31 (6.45%) |
1/40 (2.50%) |
4/38 (10.53%) |
3/39 (7.69%) |
2/15 (13.33%) |
3/29 (10.34%) |
0/12 (0.00%) |
0/21 (0.00%) |
4/52 (7.69%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Viral infection |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
1/13 (7.69%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Viral rhinitis |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
1/9 (11.11%) |
Injury, poisoning and procedural complications |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contrast media reaction |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
1/12 (8.33%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
1/39 (2.56%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Contusion |
0/12 (0.00%) |
0/16 (0.00%) |
1/13 (7.69%) |
0/13 (0.00%) |
0/12 (0.00%) |
1/31 (3.23%) |
3/40 (7.50%) |
0/38 (0.00%) |
2/39 (5.13%) |
1/15 (6.67%) |
0/29 (0.00%) |
0/12 (0.00%) |
1/21 (4.76%) |
2/52 (3.85%) |
0/9 (0.00%) |
0/15 (0.00%) |
1/9 (11.11%) |
Facial bones fracture |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
1/15 (6.67%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
1/52 (1.92%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Fall |
0/12 (0.00%) |
1/16 (6.25%) |
0/13 (0.00%) |
0/13 (0.00%) |
1/12 (8.33%) |
0/31 (0.00%) |
1/40 (2.50%) |
1/38 (2.63%) |
2/39 (5.13%) |
1/15 (6.67%) |
1/29 (3.45%) |
0/12 (0.00%) |
0/21 (0.00%) |
2/52 (3.85%) |
0/9 (0.00%) |
1/15 (6.67%) |
1/9 (11.11%) |
Foot fracture |
1/12 (8.33%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
1/52 (1.92%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Hip fracture |
0/12 (0.00%) |
0/16 (0.00%) |
1/13 (7.69%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Infusion related reaction |
0/12 (0.00%) |
2/16 (12.50%) |
1/13 (7.69%) |
1/13 (7.69%) |
0/12 (0.00%) |
0/31 (0.00%) |
1/40 (2.50%) |
3/38 (7.89%) |
0/39 (0.00%) |
4/15 (26.67%) |
3/29 (10.34%) |
1/12 (8.33%) |
2/21 (9.52%) |
1/52 (1.92%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Laceration |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
1/15 (6.67%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Post procedural complication |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
1/9 (11.11%) |
Post procedural contusion |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
1/9 (11.11%) |
0/15 (0.00%) |
0/9 (0.00%) |
Procedural pain |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
1/15 (6.67%) |
1/29 (3.45%) |
0/12 (0.00%) |
0/21 (0.00%) |
1/52 (1.92%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Procedural vomiting |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
1/9 (11.11%) |
Radiation pneumonitis |
0/12 (0.00%) |
0/16 (0.00%) |
1/13 (7.69%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
1/39 (2.56%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Skin abrasion |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
1/12 (8.33%) |
0/21 (0.00%) |
1/52 (1.92%) |
0/9 (0.00%) |
1/15 (6.67%) |
0/9 (0.00%) |
Urinary retention postoperative |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
1/15 (6.67%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Wrist fracture |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
1/12 (8.33%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Investigations |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Alanine aminotransferase increased |
0/12 (0.00%) |
0/16 (0.00%) |
1/13 (7.69%) |
0/13 (0.00%) |
0/12 (0.00%) |
1/31 (3.23%) |
8/40 (20.00%) |
1/38 (2.63%) |
1/39 (2.56%) |
1/15 (6.67%) |
1/29 (3.45%) |
0/12 (0.00%) |
3/21 (14.29%) |
2/52 (3.85%) |
0/9 (0.00%) |
4/15 (26.67%) |
1/9 (11.11%) |
Amylase increased |
0/12 (0.00%) |
2/16 (12.50%) |
2/13 (15.38%) |
2/13 (15.38%) |
1/12 (8.33%) |
5/31 (16.13%) |
2/40 (5.00%) |
8/38 (21.05%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
1/21 (4.76%) |
2/52 (3.85%) |
0/9 (0.00%) |
3/15 (20.00%) |
1/9 (11.11%) |
Aspartate aminotransferase increased |
0/12 (0.00%) |
0/16 (0.00%) |
1/13 (7.69%) |
0/13 (0.00%) |
0/12 (0.00%) |
2/31 (6.45%) |
8/40 (20.00%) |
1/38 (2.63%) |
1/39 (2.56%) |
1/15 (6.67%) |
0/29 (0.00%) |
0/12 (0.00%) |
3/21 (14.29%) |
2/52 (3.85%) |
0/9 (0.00%) |
4/15 (26.67%) |
0/9 (0.00%) |
Blood alkaline phosphatase increased |
0/12 (0.00%) |
1/16 (6.25%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
1/31 (3.23%) |
3/40 (7.50%) |
1/38 (2.63%) |
0/39 (0.00%) |
2/15 (13.33%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
1/15 (6.67%) |
0/9 (0.00%) |
Blood bilirubin increased |
0/12 (0.00%) |
0/16 (0.00%) |
1/13 (7.69%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
1/40 (2.50%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Blood corticotrophin decreased |
0/12 (0.00%) |
1/16 (6.25%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
1/15 (6.67%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Blood creatine increased |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
2/15 (13.33%) |
0/9 (0.00%) |
Blood creatinine increased |
1/12 (8.33%) |
0/16 (0.00%) |
3/13 (23.08%) |
0/13 (0.00%) |
0/12 (0.00%) |
2/31 (6.45%) |
0/40 (0.00%) |
5/38 (13.16%) |
3/39 (7.69%) |
1/15 (6.67%) |
3/29 (10.34%) |
0/12 (0.00%) |
1/21 (4.76%) |
0/52 (0.00%) |
0/9 (0.00%) |
2/15 (13.33%) |
0/9 (0.00%) |
Blood lactate dehydrogenase increased |
0/12 (0.00%) |
0/16 (0.00%) |
1/13 (7.69%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Blood potassium decreased |
0/12 (0.00%) |
1/16 (6.25%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
1/29 (3.45%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Blood thyroid stimulating hormone decreased |
1/12 (8.33%) |
0/16 (0.00%) |
1/13 (7.69%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
2/40 (5.00%) |
1/38 (2.63%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Blood thyroid stimulating hormone increased |
1/12 (8.33%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
1/52 (1.92%) |
0/9 (0.00%) |
1/15 (6.67%) |
0/9 (0.00%) |
Breath sounds abnormal |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
1/13 (7.69%) |
0/12 (0.00%) |
0/31 (0.00%) |
1/40 (2.50%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Creatinine renal clearance decreased |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
1/15 (6.67%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Csf protein increased |
0/12 (0.00%) |
1/16 (6.25%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Haemoglobin decreased |
1/12 (8.33%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
2/39 (5.13%) |
0/15 (0.00%) |
2/29 (6.90%) |
0/12 (0.00%) |
1/21 (4.76%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
1/9 (11.11%) |
Heart rate increased |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
1/13 (7.69%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
International normalised ratio increased |
0/12 (0.00%) |
0/16 (0.00%) |
1/13 (7.69%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Lipase increased |
0/12 (0.00%) |
2/16 (12.50%) |
1/13 (7.69%) |
1/13 (7.69%) |
1/12 (8.33%) |
5/31 (16.13%) |
3/40 (7.50%) |
8/38 (21.05%) |
1/39 (2.56%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
1/21 (4.76%) |
1/52 (1.92%) |
0/9 (0.00%) |
3/15 (20.00%) |
2/9 (22.22%) |
Lymphocyte count decreased |
1/12 (8.33%) |
0/16 (0.00%) |
1/13 (7.69%) |
0/13 (0.00%) |
0/12 (0.00%) |
1/31 (3.23%) |
4/40 (10.00%) |
3/38 (7.89%) |
2/39 (5.13%) |
1/15 (6.67%) |
1/29 (3.45%) |
0/12 (0.00%) |
0/21 (0.00%) |
1/52 (1.92%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Neutrophil count decreased |
2/12 (16.67%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
2/29 (6.90%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Platelet count decreased |
3/12 (25.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
1/40 (2.50%) |
0/38 (0.00%) |
1/39 (2.56%) |
0/15 (0.00%) |
3/29 (10.34%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
1/9 (11.11%) |
Thyroxine increased |
0/12 (0.00%) |
0/16 (0.00%) |
1/13 (7.69%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
1/40 (2.50%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Transaminases increased |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
1/31 (3.23%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
1/52 (1.92%) |
2/9 (22.22%) |
1/15 (6.67%) |
0/9 (0.00%) |
Tri-iodothyronine increased |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
1/15 (6.67%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Troponin t increased |
1/12 (8.33%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Urine output decreased |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
1/15 (6.67%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Weight decreased |
0/12 (0.00%) |
2/16 (12.50%) |
1/13 (7.69%) |
1/13 (7.69%) |
0/12 (0.00%) |
1/31 (3.23%) |
4/40 (10.00%) |
5/38 (13.16%) |
7/39 (17.95%) |
0/15 (0.00%) |
3/29 (10.34%) |
1/12 (8.33%) |
2/21 (9.52%) |
4/52 (7.69%) |
1/9 (11.11%) |
3/15 (20.00%) |
1/9 (11.11%) |
Weight increased |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
2/38 (5.26%) |
0/39 (0.00%) |
0/15 (0.00%) |
1/29 (3.45%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
White blood cell count decreased |
2/12 (16.67%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
2/29 (6.90%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
1/15 (6.67%) |
0/9 (0.00%) |
White blood cell count increased |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
2/40 (5.00%) |
1/38 (2.63%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
1/52 (1.92%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Metabolism and nutrition disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Decreased appetite |
8/12 (66.67%) |
8/16 (50.00%) |
1/13 (7.69%) |
3/13 (23.08%) |
2/12 (16.67%) |
4/31 (12.90%) |
8/40 (20.00%) |
11/38 (28.95%) |
14/39 (35.90%) |
9/15 (60.00%) |
10/29 (34.48%) |
1/12 (8.33%) |
6/21 (28.57%) |
9/52 (17.31%) |
6/9 (66.67%) |
6/15 (40.00%) |
3/9 (33.33%) |
Dehydration |
1/12 (8.33%) |
3/16 (18.75%) |
0/13 (0.00%) |
1/13 (7.69%) |
0/12 (0.00%) |
1/31 (3.23%) |
3/40 (7.50%) |
1/38 (2.63%) |
5/39 (12.82%) |
1/15 (6.67%) |
2/29 (6.90%) |
0/12 (0.00%) |
3/21 (14.29%) |
3/52 (5.77%) |
0/9 (0.00%) |
4/15 (26.67%) |
0/9 (0.00%) |
Hypercalcaemia |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
3/31 (9.68%) |
0/40 (0.00%) |
2/38 (5.26%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
1/52 (1.92%) |
1/9 (11.11%) |
0/15 (0.00%) |
0/9 (0.00%) |
Hyperglycaemia |
1/12 (8.33%) |
1/16 (6.25%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
3/31 (9.68%) |
1/40 (2.50%) |
0/38 (0.00%) |
2/39 (5.13%) |
1/15 (6.67%) |
6/29 (20.69%) |
0/12 (0.00%) |
0/21 (0.00%) |
2/52 (3.85%) |
1/9 (11.11%) |
2/15 (13.33%) |
0/9 (0.00%) |
Hyperkalaemia |
0/12 (0.00%) |
1/16 (6.25%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
1/31 (3.23%) |
1/40 (2.50%) |
3/38 (7.89%) |
2/39 (5.13%) |
1/15 (6.67%) |
1/29 (3.45%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
1/15 (6.67%) |
0/9 (0.00%) |
Hypermagnesaemia |
0/12 (0.00%) |
1/16 (6.25%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
1/31 (3.23%) |
0/40 (0.00%) |
1/38 (2.63%) |
1/39 (2.56%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Hypoalbuminaemia |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
1/31 (3.23%) |
1/40 (2.50%) |
3/38 (7.89%) |
1/39 (2.56%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
1/21 (4.76%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Hypocalcaemia |
0/12 (0.00%) |
1/16 (6.25%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
1/31 (3.23%) |
2/40 (5.00%) |
1/38 (2.63%) |
0/39 (0.00%) |
1/15 (6.67%) |
1/29 (3.45%) |
0/12 (0.00%) |
1/21 (4.76%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Hypokalaemia |
3/12 (25.00%) |
0/16 (0.00%) |
1/13 (7.69%) |
0/13 (0.00%) |
0/12 (0.00%) |
1/31 (3.23%) |
2/40 (5.00%) |
1/38 (2.63%) |
3/39 (7.69%) |
2/15 (13.33%) |
1/29 (3.45%) |
2/12 (16.67%) |
0/21 (0.00%) |
2/52 (3.85%) |
1/9 (11.11%) |
1/15 (6.67%) |
0/9 (0.00%) |
Hypomagnesaemia |
3/12 (25.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
1/13 (7.69%) |
0/12 (0.00%) |
1/31 (3.23%) |
1/40 (2.50%) |
1/38 (2.63%) |
0/39 (0.00%) |
1/15 (6.67%) |
3/29 (10.34%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
1/9 (11.11%) |
0/15 (0.00%) |
0/9 (0.00%) |
Hyponatraemia |
1/12 (8.33%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
1/12 (8.33%) |
2/31 (6.45%) |
3/40 (7.50%) |
2/38 (5.26%) |
3/39 (7.69%) |
0/15 (0.00%) |
1/29 (3.45%) |
1/12 (8.33%) |
0/21 (0.00%) |
1/52 (1.92%) |
1/9 (11.11%) |
2/15 (13.33%) |
0/9 (0.00%) |
Hypovolaemia |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
2/15 (13.33%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Iron deficiency |
0/12 (0.00%) |
0/16 (0.00%) |
1/13 (7.69%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Lactic acidosis |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
1/15 (6.67%) |
0/9 (0.00%) |
Metabolic acidosis |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
1/15 (6.67%) |
0/9 (0.00%) |
Musculoskeletal and connective tissue disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Arthralgia |
2/12 (16.67%) |
3/16 (18.75%) |
1/13 (7.69%) |
1/13 (7.69%) |
2/12 (16.67%) |
9/31 (29.03%) |
11/40 (27.50%) |
8/38 (21.05%) |
4/39 (10.26%) |
5/15 (33.33%) |
14/29 (48.28%) |
3/12 (25.00%) |
4/21 (19.05%) |
9/52 (17.31%) |
1/9 (11.11%) |
4/15 (26.67%) |
2/9 (22.22%) |
Arthritis |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
1/15 (6.67%) |
1/9 (11.11%) |
Back pain |
3/12 (25.00%) |
4/16 (25.00%) |
1/13 (7.69%) |
4/13 (30.77%) |
0/12 (0.00%) |
1/31 (3.23%) |
3/40 (7.50%) |
3/38 (7.89%) |
11/39 (28.21%) |
3/15 (20.00%) |
7/29 (24.14%) |
1/12 (8.33%) |
7/21 (33.33%) |
8/52 (15.38%) |
1/9 (11.11%) |
1/15 (6.67%) |
1/9 (11.11%) |
Bone pain |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
1/12 (8.33%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
1/39 (2.56%) |
0/15 (0.00%) |
2/29 (6.90%) |
0/12 (0.00%) |
0/21 (0.00%) |
1/52 (1.92%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Coccydynia |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
1/13 (7.69%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Costochondritis |
1/12 (8.33%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Flank pain |
2/12 (16.67%) |
1/16 (6.25%) |
1/13 (7.69%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
2/29 (6.90%) |
1/12 (8.33%) |
2/21 (9.52%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Groin pain |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
1/31 (3.23%) |
0/40 (0.00%) |
0/38 (0.00%) |
1/39 (2.56%) |
0/15 (0.00%) |
0/29 (0.00%) |
1/12 (8.33%) |
1/21 (4.76%) |
2/52 (3.85%) |
0/9 (0.00%) |
1/15 (6.67%) |
0/9 (0.00%) |
Intervertebral disc protrusion |
0/12 (0.00%) |
1/16 (6.25%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Joint swelling |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
1/12 (8.33%) |
2/31 (6.45%) |
1/40 (2.50%) |
1/38 (2.63%) |
1/39 (2.56%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
2/21 (9.52%) |
2/52 (3.85%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Limb discomfort |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
1/13 (7.69%) |
0/12 (0.00%) |
1/31 (3.23%) |
0/40 (0.00%) |
1/38 (2.63%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Muscle spasms |
1/12 (8.33%) |
0/16 (0.00%) |
0/13 (0.00%) |
2/13 (15.38%) |
0/12 (0.00%) |
1/31 (3.23%) |
2/40 (5.00%) |
0/38 (0.00%) |
3/39 (7.69%) |
0/15 (0.00%) |
3/29 (10.34%) |
1/12 (8.33%) |
3/21 (14.29%) |
4/52 (7.69%) |
1/9 (11.11%) |
1/15 (6.67%) |
0/9 (0.00%) |
Muscular weakness |
0/12 (0.00%) |
1/16 (6.25%) |
0/13 (0.00%) |
0/13 (0.00%) |
1/12 (8.33%) |
0/31 (0.00%) |
1/40 (2.50%) |
1/38 (2.63%) |
4/39 (10.26%) |
2/15 (13.33%) |
3/29 (10.34%) |
1/12 (8.33%) |
1/21 (4.76%) |
1/52 (1.92%) |
2/9 (22.22%) |
1/15 (6.67%) |
0/9 (0.00%) |
Musculoskeletal chest pain |
0/12 (0.00%) |
0/16 (0.00%) |
3/13 (23.08%) |
0/13 (0.00%) |
0/12 (0.00%) |
1/31 (3.23%) |
2/40 (5.00%) |
2/38 (5.26%) |
3/39 (7.69%) |
0/15 (0.00%) |
4/29 (13.79%) |
1/12 (8.33%) |
5/21 (23.81%) |
4/52 (7.69%) |
1/9 (11.11%) |
1/15 (6.67%) |
0/9 (0.00%) |
Musculoskeletal discomfort |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
2/13 (15.38%) |
0/12 (0.00%) |
1/31 (3.23%) |
0/40 (0.00%) |
0/38 (0.00%) |
1/39 (2.56%) |
0/15 (0.00%) |
4/29 (13.79%) |
1/12 (8.33%) |
0/21 (0.00%) |
3/52 (5.77%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Musculoskeletal pain |
0/12 (0.00%) |
1/16 (6.25%) |
2/13 (15.38%) |
2/13 (15.38%) |
1/12 (8.33%) |
3/31 (9.68%) |
4/40 (10.00%) |
1/38 (2.63%) |
2/39 (5.13%) |
0/15 (0.00%) |
4/29 (13.79%) |
3/12 (25.00%) |
5/21 (23.81%) |
7/52 (13.46%) |
2/9 (22.22%) |
0/15 (0.00%) |
1/9 (11.11%) |
Musculoskeletal stiffness |
1/12 (8.33%) |
0/16 (0.00%) |
1/13 (7.69%) |
0/13 (0.00%) |
1/12 (8.33%) |
0/31 (0.00%) |
2/40 (5.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
2/12 (16.67%) |
0/21 (0.00%) |
3/52 (5.77%) |
0/9 (0.00%) |
0/15 (0.00%) |
2/9 (22.22%) |
Myalgia |
0/12 (0.00%) |
3/16 (18.75%) |
1/13 (7.69%) |
1/13 (7.69%) |
2/12 (16.67%) |
5/31 (16.13%) |
5/40 (12.50%) |
4/38 (10.53%) |
5/39 (12.82%) |
1/15 (6.67%) |
8/29 (27.59%) |
0/12 (0.00%) |
4/21 (19.05%) |
5/52 (9.62%) |
0/9 (0.00%) |
1/15 (6.67%) |
2/9 (22.22%) |
Neck pain |
1/12 (8.33%) |
1/16 (6.25%) |
0/13 (0.00%) |
1/13 (7.69%) |
0/12 (0.00%) |
2/31 (6.45%) |
2/40 (5.00%) |
4/38 (10.53%) |
5/39 (12.82%) |
1/15 (6.67%) |
1/29 (3.45%) |
2/12 (16.67%) |
1/21 (4.76%) |
0/52 (0.00%) |
1/9 (11.11%) |
0/15 (0.00%) |
0/9 (0.00%) |
Osteoporosis |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
1/38 (2.63%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
1/15 (6.67%) |
0/9 (0.00%) |
Pain in extremity |
1/12 (8.33%) |
0/16 (0.00%) |
1/13 (7.69%) |
1/13 (7.69%) |
1/12 (8.33%) |
4/31 (12.90%) |
3/40 (7.50%) |
3/38 (7.89%) |
7/39 (17.95%) |
0/15 (0.00%) |
5/29 (17.24%) |
3/12 (25.00%) |
4/21 (19.05%) |
8/52 (15.38%) |
0/9 (0.00%) |
0/15 (0.00%) |
1/9 (11.11%) |
Pain in jaw |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
1/31 (3.23%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
1/52 (1.92%) |
0/9 (0.00%) |
0/15 (0.00%) |
1/9 (11.11%) |
Periarthritis |
0/12 (0.00%) |
0/16 (0.00%) |
1/13 (7.69%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Synovial cyst |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
1/31 (3.23%) |
1/40 (2.50%) |
2/38 (5.26%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
1/15 (6.67%) |
0/9 (0.00%) |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cancer pain |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
1/9 (11.11%) |
Intracranial tumour haemorrhage |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
1/12 (8.33%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Malignant pleural effusion |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
1/12 (8.33%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Metastases to central nervous system |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
2/12 (16.67%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Metastases to meninges |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
1/12 (8.33%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Neoplasm malignant |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
1/13 (7.69%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Tumour pain |
0/12 (0.00%) |
1/16 (6.25%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
1/31 (3.23%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Nervous system disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amnesia |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
1/40 (2.50%) |
1/38 (2.63%) |
1/39 (2.56%) |
1/15 (6.67%) |
1/29 (3.45%) |
0/12 (0.00%) |
0/21 (0.00%) |
1/52 (1.92%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Aphasia |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
1/15 (6.67%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Autonomic neuropathy |
0/12 (0.00%) |
1/16 (6.25%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Balance disorder |
0/12 (0.00%) |
1/16 (6.25%) |
0/13 (0.00%) |
0/13 (0.00%) |
1/12 (8.33%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
1/29 (3.45%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
1/9 (11.11%) |
0/15 (0.00%) |
0/9 (0.00%) |
Brain oedema |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
1/9 (11.11%) |
Cognitive disorder |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
2/39 (5.13%) |
1/15 (6.67%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Dizziness |
1/12 (8.33%) |
2/16 (12.50%) |
1/13 (7.69%) |
1/13 (7.69%) |
2/12 (16.67%) |
1/31 (3.23%) |
4/40 (10.00%) |
3/38 (7.89%) |
2/39 (5.13%) |
3/15 (20.00%) |
3/29 (10.34%) |
3/12 (25.00%) |
3/21 (14.29%) |
7/52 (13.46%) |
0/9 (0.00%) |
1/15 (6.67%) |
0/9 (0.00%) |
Dysarthria |
0/12 (0.00%) |
0/16 (0.00%) |
1/13 (7.69%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
1/40 (2.50%) |
1/38 (2.63%) |
0/39 (0.00%) |
0/15 (0.00%) |
1/29 (3.45%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Dysgeusia |
2/12 (16.67%) |
1/16 (6.25%) |
0/13 (0.00%) |
2/13 (15.38%) |
0/12 (0.00%) |
1/31 (3.23%) |
0/40 (0.00%) |
4/38 (10.53%) |
3/39 (7.69%) |
3/15 (20.00%) |
5/29 (17.24%) |
1/12 (8.33%) |
3/21 (14.29%) |
2/52 (3.85%) |
1/9 (11.11%) |
2/15 (13.33%) |
0/9 (0.00%) |
Headache |
1/12 (8.33%) |
3/16 (18.75%) |
1/13 (7.69%) |
1/13 (7.69%) |
0/12 (0.00%) |
5/31 (16.13%) |
5/40 (12.50%) |
6/38 (15.79%) |
6/39 (15.38%) |
3/15 (20.00%) |
9/29 (31.03%) |
1/12 (8.33%) |
4/21 (19.05%) |
3/52 (5.77%) |
0/9 (0.00%) |
3/15 (20.00%) |
0/9 (0.00%) |
Hyperaesthesia |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
1/13 (7.69%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
1/9 (11.11%) |
0/15 (0.00%) |
0/9 (0.00%) |
Hypoaesthesia |
1/12 (8.33%) |
0/16 (0.00%) |
2/13 (15.38%) |
1/13 (7.69%) |
1/12 (8.33%) |
0/31 (0.00%) |
2/40 (5.00%) |
1/38 (2.63%) |
1/39 (2.56%) |
1/15 (6.67%) |
5/29 (17.24%) |
0/12 (0.00%) |
1/21 (4.76%) |
1/52 (1.92%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Lethargy |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
1/29 (3.45%) |
1/12 (8.33%) |
1/21 (4.76%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Memory impairment |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
2/39 (5.13%) |
1/15 (6.67%) |
2/29 (6.90%) |
0/12 (0.00%) |
0/21 (0.00%) |
1/52 (1.92%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Neuropathy peripheral |
1/12 (8.33%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
2/39 (5.13%) |
2/15 (13.33%) |
14/29 (48.28%) |
3/12 (25.00%) |
1/21 (4.76%) |
4/52 (7.69%) |
0/9 (0.00%) |
2/15 (13.33%) |
0/9 (0.00%) |
Paraesthesia |
0/12 (0.00%) |
1/16 (6.25%) |
1/13 (7.69%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
1/40 (2.50%) |
2/38 (5.26%) |
0/39 (0.00%) |
0/15 (0.00%) |
3/29 (10.34%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Peripheral motor neuropathy |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
1/40 (2.50%) |
1/38 (2.63%) |
1/39 (2.56%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
1/15 (6.67%) |
0/9 (0.00%) |
Peripheral sensory neuropathy |
0/12 (0.00%) |
1/16 (6.25%) |
0/13 (0.00%) |
1/13 (7.69%) |
2/12 (16.67%) |
1/31 (3.23%) |
0/40 (0.00%) |
0/38 (0.00%) |
1/39 (2.56%) |
2/15 (13.33%) |
6/29 (20.69%) |
1/12 (8.33%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
1/15 (6.67%) |
0/9 (0.00%) |
Sciatica |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
1/13 (7.69%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
1/15 (6.67%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Seizure |
1/12 (8.33%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Syncope |
0/12 (0.00%) |
1/16 (6.25%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
1/38 (2.63%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
1/21 (4.76%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Tension headache |
0/12 (0.00%) |
1/16 (6.25%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
1/29 (3.45%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Tremor |
1/12 (8.33%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
2/31 (6.45%) |
1/40 (2.50%) |
1/38 (2.63%) |
0/39 (0.00%) |
0/15 (0.00%) |
1/29 (3.45%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
2/9 (22.22%) |
Psychiatric disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Abnormal dreams |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
1/9 (11.11%) |
Agitation |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
2/38 (5.26%) |
1/39 (2.56%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Anxiety |
2/12 (16.67%) |
1/16 (6.25%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
2/31 (6.45%) |
1/40 (2.50%) |
1/38 (2.63%) |
3/39 (7.69%) |
1/15 (6.67%) |
1/29 (3.45%) |
0/12 (0.00%) |
1/21 (4.76%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Confusional state |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
2/40 (5.00%) |
0/38 (0.00%) |
1/39 (2.56%) |
0/15 (0.00%) |
1/29 (3.45%) |
0/12 (0.00%) |
0/21 (0.00%) |
1/52 (1.92%) |
0/9 (0.00%) |
2/15 (13.33%) |
0/9 (0.00%) |
Delirium |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
1/38 (2.63%) |
0/39 (0.00%) |
1/15 (6.67%) |
1/29 (3.45%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Depression |
1/12 (8.33%) |
1/16 (6.25%) |
0/13 (0.00%) |
1/13 (7.69%) |
0/12 (0.00%) |
2/31 (6.45%) |
2/40 (5.00%) |
2/38 (5.26%) |
4/39 (10.26%) |
0/15 (0.00%) |
1/29 (3.45%) |
0/12 (0.00%) |
1/21 (4.76%) |
3/52 (5.77%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Insomnia |
1/12 (8.33%) |
1/16 (6.25%) |
0/13 (0.00%) |
0/13 (0.00%) |
1/12 (8.33%) |
6/31 (19.35%) |
4/40 (10.00%) |
7/38 (18.42%) |
6/39 (15.38%) |
2/15 (13.33%) |
6/29 (20.69%) |
0/12 (0.00%) |
1/21 (4.76%) |
9/52 (17.31%) |
0/9 (0.00%) |
1/15 (6.67%) |
1/9 (11.11%) |
Mental fatigue |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
1/15 (6.67%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Mental status changes |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
1/12 (8.33%) |
0/31 (0.00%) |
1/40 (2.50%) |
1/38 (2.63%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Mood altered |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
1/15 (6.67%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Restlessness |
1/12 (8.33%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Renal and urinary disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Acute kidney injury |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
1/31 (3.23%) |
1/40 (2.50%) |
0/38 (0.00%) |
0/39 (0.00%) |
1/15 (6.67%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Bladder pain |
0/12 (0.00%) |
0/16 (0.00%) |
1/13 (7.69%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Dysuria |
0/12 (0.00%) |
0/16 (0.00%) |
1/13 (7.69%) |
0/13 (0.00%) |
0/12 (0.00%) |
1/31 (3.23%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
1/15 (6.67%) |
1/29 (3.45%) |
0/12 (0.00%) |
1/21 (4.76%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Haematuria |
0/12 (0.00%) |
0/16 (0.00%) |
1/13 (7.69%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
1/38 (2.63%) |
1/39 (2.56%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
1/21 (4.76%) |
1/52 (1.92%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Micturition urgency |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
1/12 (8.33%) |
1/31 (3.23%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
1/29 (3.45%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Nocturia |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
2/31 (6.45%) |
1/40 (2.50%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
1/52 (1.92%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Pollakiuria |
1/12 (8.33%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
2/38 (5.26%) |
3/39 (7.69%) |
0/15 (0.00%) |
1/29 (3.45%) |
1/12 (8.33%) |
1/21 (4.76%) |
1/52 (1.92%) |
1/9 (11.11%) |
0/15 (0.00%) |
0/9 (0.00%) |
Proteinuria |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
3/12 (25.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Stress urinary incontinence |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
1/13 (7.69%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Tubulointerstitial nephritis |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
1/15 (6.67%) |
0/29 (0.00%) |
0/12 (0.00%) |
1/21 (4.76%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Urinary straining |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
1/12 (8.33%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Reproductive system and breast disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Menopausal symptoms |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
1/15 (6.67%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Pelvic pain |
0/12 (0.00%) |
0/16 (0.00%) |
1/13 (7.69%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Penile haemorrhage |
0/12 (0.00%) |
0/16 (0.00%) |
1/13 (7.69%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Respiratory, thoracic and mediastinal disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Asthma |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
1/13 (7.69%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Chronic obstructive pulmonary disease |
1/12 (8.33%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
1/31 (3.23%) |
0/40 (0.00%) |
1/38 (2.63%) |
1/39 (2.56%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
2/52 (3.85%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Cough |
6/12 (50.00%) |
6/16 (37.50%) |
3/13 (23.08%) |
8/13 (61.54%) |
5/12 (41.67%) |
11/31 (35.48%) |
12/40 (30.00%) |
13/38 (34.21%) |
13/39 (33.33%) |
5/15 (33.33%) |
15/29 (51.72%) |
7/12 (58.33%) |
9/21 (42.86%) |
28/52 (53.85%) |
3/9 (33.33%) |
6/15 (40.00%) |
3/9 (33.33%) |
Dysphonia |
0/12 (0.00%) |
1/16 (6.25%) |
0/13 (0.00%) |
1/13 (7.69%) |
1/12 (8.33%) |
2/31 (6.45%) |
1/40 (2.50%) |
0/38 (0.00%) |
2/39 (5.13%) |
0/15 (0.00%) |
3/29 (10.34%) |
2/12 (16.67%) |
1/21 (4.76%) |
6/52 (11.54%) |
1/9 (11.11%) |
0/15 (0.00%) |
2/9 (22.22%) |
Dyspnoea |
3/12 (25.00%) |
3/16 (18.75%) |
1/13 (7.69%) |
2/13 (15.38%) |
0/12 (0.00%) |
13/31 (41.94%) |
9/40 (22.50%) |
12/38 (31.58%) |
11/39 (28.21%) |
8/15 (53.33%) |
15/29 (51.72%) |
5/12 (41.67%) |
7/21 (33.33%) |
17/52 (32.69%) |
2/9 (22.22%) |
5/15 (33.33%) |
2/9 (22.22%) |
Dyspnoea exertional |
1/12 (8.33%) |
0/16 (0.00%) |
0/13 (0.00%) |
1/13 (7.69%) |
0/12 (0.00%) |
1/31 (3.23%) |
1/40 (2.50%) |
1/38 (2.63%) |
2/39 (5.13%) |
2/15 (13.33%) |
1/29 (3.45%) |
1/12 (8.33%) |
1/21 (4.76%) |
3/52 (5.77%) |
0/9 (0.00%) |
1/15 (6.67%) |
1/9 (11.11%) |
Epistaxis |
0/12 (0.00%) |
0/16 (0.00%) |
1/13 (7.69%) |
1/13 (7.69%) |
0/12 (0.00%) |
2/31 (6.45%) |
0/40 (0.00%) |
1/38 (2.63%) |
0/39 (0.00%) |
0/15 (0.00%) |
2/29 (6.90%) |
1/12 (8.33%) |
0/21 (0.00%) |
5/52 (9.62%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Haemoptysis |
3/12 (25.00%) |
0/16 (0.00%) |
2/13 (15.38%) |
0/13 (0.00%) |
2/12 (16.67%) |
1/31 (3.23%) |
3/40 (7.50%) |
2/38 (5.26%) |
4/39 (10.26%) |
1/15 (6.67%) |
1/29 (3.45%) |
0/12 (0.00%) |
2/21 (9.52%) |
2/52 (3.85%) |
0/9 (0.00%) |
1/15 (6.67%) |
1/9 (11.11%) |
Hiccups |
1/12 (8.33%) |
1/16 (6.25%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
1/40 (2.50%) |
0/38 (0.00%) |
0/39 (0.00%) |
1/15 (6.67%) |
1/29 (3.45%) |
1/12 (8.33%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Hypoxia |
1/12 (8.33%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
1/40 (2.50%) |
2/38 (5.26%) |
1/39 (2.56%) |
1/15 (6.67%) |
0/29 (0.00%) |
0/12 (0.00%) |
1/21 (4.76%) |
4/52 (7.69%) |
0/9 (0.00%) |
1/15 (6.67%) |
0/9 (0.00%) |
Laryngeal haemorrhage |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
1/12 (8.33%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Nasal congestion |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
3/31 (9.68%) |
1/40 (2.50%) |
5/38 (13.16%) |
5/39 (12.82%) |
1/15 (6.67%) |
3/29 (10.34%) |
0/12 (0.00%) |
3/21 (14.29%) |
5/52 (9.62%) |
0/9 (0.00%) |
1/15 (6.67%) |
0/9 (0.00%) |
Nasal dryness |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
1/12 (8.33%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Oropharyngeal pain |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
1/13 (7.69%) |
0/12 (0.00%) |
2/31 (6.45%) |
1/40 (2.50%) |
0/38 (0.00%) |
3/39 (7.69%) |
2/15 (13.33%) |
3/29 (10.34%) |
0/12 (0.00%) |
3/21 (14.29%) |
5/52 (9.62%) |
0/9 (0.00%) |
2/15 (13.33%) |
0/9 (0.00%) |
Pleural effusion |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
1/13 (7.69%) |
0/12 (0.00%) |
1/31 (3.23%) |
1/40 (2.50%) |
2/38 (5.26%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
1/21 (4.76%) |
1/52 (1.92%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Pleuritic pain |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
1/38 (2.63%) |
0/39 (0.00%) |
1/15 (6.67%) |
0/29 (0.00%) |
0/12 (0.00%) |
3/21 (14.29%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Pneumonitis |
0/12 (0.00%) |
0/16 (0.00%) |
1/13 (7.69%) |
0/13 (0.00%) |
0/12 (0.00%) |
2/31 (6.45%) |
1/40 (2.50%) |
2/38 (5.26%) |
2/39 (5.13%) |
1/15 (6.67%) |
0/29 (0.00%) |
2/12 (16.67%) |
1/21 (4.76%) |
3/52 (5.77%) |
1/9 (11.11%) |
0/15 (0.00%) |
1/9 (11.11%) |
Productive cough |
1/12 (8.33%) |
0/16 (0.00%) |
1/13 (7.69%) |
1/13 (7.69%) |
0/12 (0.00%) |
1/31 (3.23%) |
2/40 (5.00%) |
1/38 (2.63%) |
2/39 (5.13%) |
1/15 (6.67%) |
1/29 (3.45%) |
2/12 (16.67%) |
0/21 (0.00%) |
1/52 (1.92%) |
0/9 (0.00%) |
0/15 (0.00%) |
1/9 (11.11%) |
Pulmonary embolism |
1/12 (8.33%) |
1/16 (6.25%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
2/38 (5.26%) |
1/39 (2.56%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
1/21 (4.76%) |
1/52 (1.92%) |
0/9 (0.00%) |
1/15 (6.67%) |
0/9 (0.00%) |
Rales |
0/12 (0.00%) |
1/16 (6.25%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Respiratory disorder |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
1/9 (11.11%) |
0/15 (0.00%) |
0/9 (0.00%) |
Respiratory tract congestion |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
1/31 (3.23%) |
1/40 (2.50%) |
0/38 (0.00%) |
1/39 (2.56%) |
0/15 (0.00%) |
1/29 (3.45%) |
0/12 (0.00%) |
0/21 (0.00%) |
3/52 (5.77%) |
0/9 (0.00%) |
0/15 (0.00%) |
1/9 (11.11%) |
Rhinorrhoea |
1/12 (8.33%) |
0/16 (0.00%) |
0/13 (0.00%) |
1/13 (7.69%) |
0/12 (0.00%) |
1/31 (3.23%) |
1/40 (2.50%) |
3/38 (7.89%) |
2/39 (5.13%) |
3/15 (20.00%) |
1/29 (3.45%) |
4/12 (33.33%) |
3/21 (14.29%) |
5/52 (9.62%) |
0/9 (0.00%) |
1/15 (6.67%) |
0/9 (0.00%) |
Sinus congestion |
0/12 (0.00%) |
0/16 (0.00%) |
1/13 (7.69%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
3/40 (7.50%) |
3/38 (7.89%) |
5/39 (12.82%) |
0/15 (0.00%) |
1/29 (3.45%) |
1/12 (8.33%) |
0/21 (0.00%) |
1/52 (1.92%) |
0/9 (0.00%) |
1/15 (6.67%) |
0/9 (0.00%) |
Sneezing |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
1/12 (8.33%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
2/21 (9.52%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
1/9 (11.11%) |
Sputum discoloured |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
1/12 (8.33%) |
1/31 (3.23%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Sputum increased |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
1/13 (7.69%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
1/38 (2.63%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
1/15 (6.67%) |
0/9 (0.00%) |
Upper-airway cough syndrome |
1/12 (8.33%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
1/31 (3.23%) |
0/40 (0.00%) |
0/38 (0.00%) |
2/39 (5.13%) |
0/15 (0.00%) |
1/29 (3.45%) |
4/12 (33.33%) |
1/21 (4.76%) |
2/52 (3.85%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Vocal cord disorder |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
1/12 (8.33%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Wheezing |
1/12 (8.33%) |
0/16 (0.00%) |
1/13 (7.69%) |
0/13 (0.00%) |
0/12 (0.00%) |
3/31 (9.68%) |
1/40 (2.50%) |
3/38 (7.89%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
2/52 (3.85%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Skin and subcutaneous tissue disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Acne |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
1/52 (1.92%) |
1/9 (11.11%) |
0/15 (0.00%) |
1/9 (11.11%) |
Alopecia |
3/12 (25.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
1/12 (8.33%) |
0/31 (0.00%) |
2/40 (5.00%) |
1/38 (2.63%) |
0/39 (0.00%) |
2/15 (13.33%) |
15/29 (51.72%) |
0/12 (0.00%) |
3/21 (14.29%) |
1/52 (1.92%) |
1/9 (11.11%) |
0/15 (0.00%) |
0/9 (0.00%) |
Blister |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
1/31 (3.23%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
1/15 (6.67%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Dermal cyst |
0/12 (0.00%) |
0/16 (0.00%) |
1/13 (7.69%) |
0/13 (0.00%) |
0/12 (0.00%) |
1/31 (3.23%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Dermatitis contact |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
1/31 (3.23%) |
0/40 (0.00%) |
1/38 (2.63%) |
0/39 (0.00%) |
0/15 (0.00%) |
1/29 (3.45%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
1/9 (11.11%) |
0/15 (0.00%) |
0/9 (0.00%) |
Dry skin |
0/12 (0.00%) |
1/16 (6.25%) |
0/13 (0.00%) |
1/13 (7.69%) |
1/12 (8.33%) |
3/31 (9.68%) |
4/40 (10.00%) |
2/38 (5.26%) |
6/39 (15.38%) |
3/15 (20.00%) |
0/29 (0.00%) |
2/12 (16.67%) |
5/21 (23.81%) |
5/52 (9.62%) |
0/9 (0.00%) |
1/15 (6.67%) |
0/9 (0.00%) |
Dyshidrotic eczema |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
1/12 (8.33%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Ecchymosis |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
1/38 (2.63%) |
0/39 (0.00%) |
1/15 (6.67%) |
1/29 (3.45%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Eczema |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
2/31 (6.45%) |
0/40 (0.00%) |
0/38 (0.00%) |
1/39 (2.56%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Erythema |
0/12 (0.00%) |
1/16 (6.25%) |
0/13 (0.00%) |
1/13 (7.69%) |
0/12 (0.00%) |
1/31 (3.23%) |
0/40 (0.00%) |
1/38 (2.63%) |
0/39 (0.00%) |
1/15 (6.67%) |
0/29 (0.00%) |
0/12 (0.00%) |
3/21 (14.29%) |
2/52 (3.85%) |
1/9 (11.11%) |
0/15 (0.00%) |
0/9 (0.00%) |
Exfoliative rash |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
1/12 (8.33%) |
1/21 (4.76%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Hair texture abnormal |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
1/13 (7.69%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Hyperhidrosis |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
2/40 (5.00%) |
1/38 (2.63%) |
2/39 (5.13%) |
0/15 (0.00%) |
0/29 (0.00%) |
1/12 (8.33%) |
1/21 (4.76%) |
2/52 (3.85%) |
1/9 (11.11%) |
0/15 (0.00%) |
1/9 (11.11%) |
Nail discolouration |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
1/12 (8.33%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Nail disorder |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
3/21 (14.29%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Night sweats |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
1/13 (7.69%) |
1/12 (8.33%) |
2/31 (6.45%) |
1/40 (2.50%) |
2/38 (5.26%) |
0/39 (0.00%) |
2/15 (13.33%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
1/52 (1.92%) |
1/9 (11.11%) |
1/15 (6.67%) |
0/9 (0.00%) |
Onychoclasis |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
1/13 (7.69%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
1/21 (4.76%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
1/9 (11.11%) |
Onychomadesis |
0/12 (0.00%) |
1/16 (6.25%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Photosensitivity reaction |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
1/15 (6.67%) |
0/29 (0.00%) |
0/12 (0.00%) |
1/21 (4.76%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Pruritus |
0/12 (0.00%) |
4/16 (25.00%) |
1/13 (7.69%) |
0/13 (0.00%) |
0/12 (0.00%) |
8/31 (25.81%) |
5/40 (12.50%) |
16/38 (42.11%) |
7/39 (17.95%) |
2/15 (13.33%) |
3/29 (10.34%) |
1/12 (8.33%) |
5/21 (23.81%) |
15/52 (28.85%) |
2/9 (22.22%) |
4/15 (26.67%) |
0/9 (0.00%) |
Pruritus generalised |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
2/40 (5.00%) |
0/38 (0.00%) |
2/39 (5.13%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
2/9 (22.22%) |
0/15 (0.00%) |
0/9 (0.00%) |
Rash |
2/12 (16.67%) |
6/16 (37.50%) |
3/13 (23.08%) |
1/13 (7.69%) |
1/12 (8.33%) |
11/31 (35.48%) |
14/40 (35.00%) |
8/38 (21.05%) |
6/39 (15.38%) |
6/15 (40.00%) |
10/29 (34.48%) |
2/12 (16.67%) |
13/21 (61.90%) |
15/52 (28.85%) |
2/9 (22.22%) |
6/15 (40.00%) |
2/9 (22.22%) |
Rash generalised |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
2/40 (5.00%) |
0/38 (0.00%) |
4/39 (10.26%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
1/21 (4.76%) |
0/52 (0.00%) |
1/9 (11.11%) |
0/15 (0.00%) |
0/9 (0.00%) |
Rash macular |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
1/12 (8.33%) |
2/31 (6.45%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
1/12 (8.33%) |
1/21 (4.76%) |
3/52 (5.77%) |
0/9 (0.00%) |
1/15 (6.67%) |
0/9 (0.00%) |
Rash maculo-papular |
1/12 (8.33%) |
3/16 (18.75%) |
1/13 (7.69%) |
0/13 (0.00%) |
0/12 (0.00%) |
4/31 (12.90%) |
4/40 (10.00%) |
7/38 (18.42%) |
4/39 (10.26%) |
1/15 (6.67%) |
1/29 (3.45%) |
1/12 (8.33%) |
1/21 (4.76%) |
1/52 (1.92%) |
1/9 (11.11%) |
2/15 (13.33%) |
1/9 (11.11%) |
Rash papular |
0/12 (0.00%) |
0/16 (0.00%) |
1/13 (7.69%) |
0/13 (0.00%) |
0/12 (0.00%) |
1/31 (3.23%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
1/21 (4.76%) |
2/52 (3.85%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Rash pruritic |
0/12 (0.00%) |
2/16 (12.50%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
2/40 (5.00%) |
1/38 (2.63%) |
4/39 (10.26%) |
0/15 (0.00%) |
2/29 (6.90%) |
0/12 (0.00%) |
1/21 (4.76%) |
2/52 (3.85%) |
1/9 (11.11%) |
0/15 (0.00%) |
1/9 (11.11%) |
Scab |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
1/38 (2.63%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
1/9 (11.11%) |
Skin exfoliation |
0/12 (0.00%) |
1/16 (6.25%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
1/40 (2.50%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
2/21 (9.52%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Skin fissures |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
1/40 (2.50%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
5/21 (23.81%) |
1/52 (1.92%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Skin hyperpigmentation |
1/12 (8.33%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Skin hypertrophy |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
1/13 (7.69%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Skin hypopigmentation |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
2/21 (9.52%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Skin mass |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
1/9 (11.11%) |
Skin plaque |
0/12 (0.00%) |
1/16 (6.25%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Skin ulcer |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
1/38 (2.63%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
1/12 (8.33%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Solar dermatitis |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
1/9 (11.11%) |
Swelling face |
0/12 (0.00%) |
1/16 (6.25%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
1/38 (2.63%) |
0/39 (0.00%) |
0/15 (0.00%) |
1/29 (3.45%) |
0/12 (0.00%) |
0/21 (0.00%) |
2/52 (3.85%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Urticaria |
0/12 (0.00%) |
2/16 (12.50%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
1/31 (3.23%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
1/15 (6.67%) |
0/9 (0.00%) |
Vascular disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Arterial thrombosis |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
1/15 (6.67%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Deep vein thrombosis |
0/12 (0.00%) |
1/16 (6.25%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
1/39 (2.56%) |
1/15 (6.67%) |
1/29 (3.45%) |
0/12 (0.00%) |
0/21 (0.00%) |
1/52 (1.92%) |
0/9 (0.00%) |
1/15 (6.67%) |
0/9 (0.00%) |
Flushing |
0/12 (0.00%) |
1/16 (6.25%) |
0/13 (0.00%) |
0/13 (0.00%) |
1/12 (8.33%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
1/39 (2.56%) |
1/15 (6.67%) |
0/29 (0.00%) |
0/12 (0.00%) |
2/21 (9.52%) |
0/52 (0.00%) |
2/9 (22.22%) |
1/15 (6.67%) |
0/9 (0.00%) |
Haemorrhage |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
1/9 (11.11%) |
0/15 (0.00%) |
0/9 (0.00%) |
Hot flush |
0/12 (0.00%) |
1/16 (6.25%) |
1/13 (7.69%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
2/40 (5.00%) |
1/38 (2.63%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
1/52 (1.92%) |
0/9 (0.00%) |
0/15 (0.00%) |
1/9 (11.11%) |
Hypertension |
1/12 (8.33%) |
1/16 (6.25%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
1/31 (3.23%) |
0/40 (0.00%) |
3/38 (7.89%) |
4/39 (10.26%) |
2/15 (13.33%) |
4/29 (13.79%) |
1/12 (8.33%) |
1/21 (4.76%) |
2/52 (3.85%) |
0/9 (0.00%) |
0/15 (0.00%) |
1/9 (11.11%) |
Hypotension |
1/12 (8.33%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
2/40 (5.00%) |
4/38 (10.53%) |
1/39 (2.56%) |
2/15 (13.33%) |
1/29 (3.45%) |
2/12 (16.67%) |
1/21 (4.76%) |
0/52 (0.00%) |
0/9 (0.00%) |
1/15 (6.67%) |
0/9 (0.00%) |
Orthostatic hypotension |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
1/15 (6.67%) |
0/9 (0.00%) |
Thrombosis |
0/12 (0.00%) |
0/16 (0.00%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
1/15 (6.67%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Vena cava thrombosis |
0/12 (0.00%) |
1/16 (6.25%) |
0/13 (0.00%) |
0/13 (0.00%) |
0/12 (0.00%) |
0/31 (0.00%) |
0/40 (0.00%) |
0/38 (0.00%) |
0/39 (0.00%) |
0/15 (0.00%) |
0/29 (0.00%) |
0/12 (0.00%) |
0/21 (0.00%) |
0/52 (0.00%) |
0/9 (0.00%) |
0/15 (0.00%) |
0/9 (0.00%) |
Indicates events were collected by systematic assessment
Term from vocabulary, MedDRA 19.0
|