Time Frame |
From date of first dose of the study drugs up to 30 days after the last dose (up to 74 months)
|
Adverse Event Reporting Description |
The safety analysis set included all participants who received at least one dose of study drug.
|
|
Arm/Group Title
|
Phase 1b, Lenvatinib 24 mg/Day + Pembrolizumab 200 mg: RCC
|
Phase 1b, Lenvatinib 24 mg/Day + Pembrolizumab 200 mg: NSCLC
|
Phase 1b and 2, Lenvatinib 20 mg/Day+Pembrolizumab 200 mg: EC
|
Phase 1b and 2, Lenvatinib 20 mg/Day+Pembrolizumab 200 mg: RCC
|
Phase 1b and 2, Lenvatinib 20 mg/Day+Pembrolizumab 200 mg: Melanoma
|
Phase 1b and 2, Lenvatinib 20 mg/Day+Pembrolizumab 200 mg: NSCLC
|
Phase 1b and 2,Lenvatinib 20 mg/Day+Pembrolizumab 200 mg: HNSCC
|
Phase 1b and 2, Lenvatinib 20 mg/Day+Pembrolizumab 200 mg: UC
|
Phase1b and 2, Lenvatinib 20mg/Day+Pembrolizumab 200 mg: Leiomyosarcoma
|
Arm/Group Description |
Participants with RCC received lenv...
|
Participant with NSCLC received len...
|
Participants with EC received lenva...
|
Participants with RCC received lenv...
|
Participants with Melanoma received...
|
Participants with NSCLC received le...
|
Participants with HNSCC received le...
|
Participants with UC received lenva...
|
Participant with Leiomyosarcoma rec...
|
Arm/Group Description |
Participants with RCC received lenvatinib 24 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Participant with NSCLC received lenvatinib 24 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Participants with EC received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Participants with RCC received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Participants with Melanoma received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Participants with NSCLC received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Participants with HNSCC received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Participants with UC received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
Participant with Leiomyosarcoma received lenvatinib 20 mg/day, capsules, orally, once daily in combination with pembrolizumab 200 mg, intravenous, infusion, Q3W on Day 1 of each cycle (cycle length=21 days) until PD, development of unacceptable toxicity, participant choice, withdrawal of consent, lost to follow up or discontinuation of this study by the sponsor.
|
|
|
Phase 1b, Lenvatinib 24 mg/Day + Pembrolizumab 200 mg: RCC
|
Phase 1b, Lenvatinib 24 mg/Day + Pembrolizumab 200 mg: NSCLC
|
Phase 1b and 2, Lenvatinib 20 mg/Day+Pembrolizumab 200 mg: EC
|
Phase 1b and 2, Lenvatinib 20 mg/Day+Pembrolizumab 200 mg: RCC
|
Phase 1b and 2, Lenvatinib 20 mg/Day+Pembrolizumab 200 mg: Melanoma
|
Phase 1b and 2, Lenvatinib 20 mg/Day+Pembrolizumab 200 mg: NSCLC
|
Phase 1b and 2,Lenvatinib 20 mg/Day+Pembrolizumab 200 mg: HNSCC
|
Phase 1b and 2, Lenvatinib 20 mg/Day+Pembrolizumab 200 mg: UC
|
Phase1b and 2, Lenvatinib 20mg/Day+Pembrolizumab 200 mg: Leiomyosarcoma
|
|
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 |
1/2 (50.00%)
|
|
1/1 (100.00%)
|
|
88/124 (70.97%)
|
|
74/145 (51.03%)
|
|
15/21 (71.43%)
|
|
16/21 (76.19%)
|
|
15/22 (68.18%)
|
|
16/20 (80.00%)
|
|
1/1 (100.00%)
|
|
|
|
Phase 1b, Lenvatinib 24 mg/Day + Pembrolizumab 200 mg: RCC
|
Phase 1b, Lenvatinib 24 mg/Day + Pembrolizumab 200 mg: NSCLC
|
Phase 1b and 2, Lenvatinib 20 mg/Day+Pembrolizumab 200 mg: EC
|
Phase 1b and 2, Lenvatinib 20 mg/Day+Pembrolizumab 200 mg: RCC
|
Phase 1b and 2, Lenvatinib 20 mg/Day+Pembrolizumab 200 mg: Melanoma
|
Phase 1b and 2, Lenvatinib 20 mg/Day+Pembrolizumab 200 mg: NSCLC
|
Phase 1b and 2,Lenvatinib 20 mg/Day+Pembrolizumab 200 mg: HNSCC
|
Phase 1b and 2, Lenvatinib 20 mg/Day+Pembrolizumab 200 mg: UC
|
Phase1b and 2, Lenvatinib 20mg/Day+Pembrolizumab 200 mg: Leiomyosarcoma
|
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Total |
1/2 (50.00%)
|
|
1/1 (100.00%)
|
|
73/124 (58.87%)
|
|
81/145 (55.86%)
|
|
12/21 (57.14%)
|
|
15/21 (71.43%)
|
|
12/22 (54.55%)
|
|
17/20 (85.00%)
|
|
0/1 (0.00%)
|
|
Blood and lymphatic system disorders |
|
|
|
|
|
|
|
|
|
Anaemia |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
1/124 (0.81%)
|
1 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Autoimmune haemolytic anaemia |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
1/145 (0.69%)
|
1 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Leukocytosis |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
1/20 (5.00%)
|
1 |
0/1 (0.00%)
|
0 |
Thrombocytopenia |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
1/124 (0.81%)
|
2 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Cardiac disorders |
|
|
|
|
|
|
|
|
|
Acute coronary syndrome |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
1/145 (0.69%)
|
1 |
0/21 (0.00%)
|
0 |
1/21 (4.76%)
|
1 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Acute myocardial infarction |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
1/124 (0.81%)
|
1 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Angina pectoris |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
1/124 (0.81%)
|
1 |
2/145 (1.38%)
|
2 |
0/21 (0.00%)
|
0 |
1/21 (4.76%)
|
1 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Atrial fibrillation |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
1/124 (0.81%)
|
1 |
0/145 (0.00%)
|
0 |
1/21 (4.76%)
|
1 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Atrial tachycardia |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
1/145 (0.69%)
|
1 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Cardiac arrest |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
3/145 (2.07%)
|
3 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Cardiac failure |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
1/124 (0.81%)
|
1 |
1/145 (0.69%)
|
1 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
1/20 (5.00%)
|
1 |
0/1 (0.00%)
|
0 |
Cardiac failure congestive |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
2/124 (1.61%)
|
2 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
1/22 (4.55%)
|
1 |
1/20 (5.00%)
|
1 |
0/1 (0.00%)
|
0 |
Coronary artery disease |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
1/124 (0.81%)
|
1 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Intracardiac thrombus |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
1/145 (0.69%)
|
1 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Myocardial infarction |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
1/124 (0.81%)
|
1 |
3/145 (2.07%)
|
3 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
1/20 (5.00%)
|
1 |
0/1 (0.00%)
|
0 |
Pericardial effusion |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
1/21 (4.76%)
|
1 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Supraventricular tachycardia |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
1/145 (0.69%)
|
1 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
1/22 (4.55%)
|
1 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Tachycardia |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
1/145 (0.69%)
|
1 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Endocrine disorders |
|
|
|
|
|
|
|
|
|
Adrenal insufficiency |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
3/124 (2.42%)
|
3 |
2/145 (1.38%)
|
3 |
1/21 (4.76%)
|
1 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Hypothyroidism |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
1/124 (0.81%)
|
1 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Eye disorders |
|
|
|
|
|
|
|
|
|
Retinal vein occlusion |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
1/124 (0.81%)
|
1 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Gastrointestinal disorders |
|
|
|
|
|
|
|
|
|
Abdominal pain |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
6/124 (4.84%)
|
9 |
4/145 (2.76%)
|
4 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
1/20 (5.00%)
|
1 |
0/1 (0.00%)
|
0 |
Abdominal pain upper |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
1/124 (0.81%)
|
1 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Anal fistula |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
1/145 (0.69%)
|
1 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Ascites |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
1/124 (0.81%)
|
1 |
1/145 (0.69%)
|
1 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Colitis |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
2/124 (1.61%)
|
2 |
2/145 (1.38%)
|
2 |
0/21 (0.00%)
|
0 |
1/21 (4.76%)
|
2 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Colitis ischaemic |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
1/124 (0.81%)
|
1 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Constipation |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
2/145 (1.38%)
|
2 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
1/20 (5.00%)
|
1 |
0/1 (0.00%)
|
0 |
Diarrhoea |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
2/124 (1.61%)
|
2 |
3/145 (2.07%)
|
3 |
0/21 (0.00%)
|
0 |
2/21 (9.52%)
|
2 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Dysphagia |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
1/145 (0.69%)
|
2 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
1/22 (4.55%)
|
1 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Enterovesical fistula |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
1/22 (4.55%)
|
1 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Gastric perforation |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
2/124 (1.61%)
|
2 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Gastric ulcer |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
1/145 (0.69%)
|
1 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Gastrointestinal haemorrhage |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
1/124 (0.81%)
|
1 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
1/20 (5.00%)
|
1 |
0/1 (0.00%)
|
0 |
Gastrointestinal perforation |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
1/124 (0.81%)
|
2 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Immune-mediated enterocolitis |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
2/145 (1.38%)
|
2 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Intestinal obstruction |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
2/124 (1.61%)
|
3 |
1/145 (0.69%)
|
1 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Intestinal ulcer perforation |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
1/124 (0.81%)
|
1 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Jejunal perforation |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
1/145 (0.69%)
|
1 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Large intestinal obstruction |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
1/124 (0.81%)
|
1 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Large intestinal ulcer |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
1/124 (0.81%)
|
1 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Large intestine perforation |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
1/145 (0.69%)
|
1 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
1/20 (5.00%)
|
1 |
0/1 (0.00%)
|
0 |
Nausea |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
6/124 (4.84%)
|
6 |
3/145 (2.07%)
|
3 |
0/21 (0.00%)
|
0 |
1/21 (4.76%)
|
1 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Pancreatitis |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
3/124 (2.42%)
|
3 |
1/145 (0.69%)
|
1 |
1/21 (4.76%)
|
1 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Pancreatitis acute |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
1/124 (0.81%)
|
1 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Pneumoperitoneum |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
1/145 (0.69%)
|
1 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Proctalgia |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
1/145 (0.69%)
|
1 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Rectal ulcer haemorrhage |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
1/124 (0.81%)
|
1 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Small intestinal haemorrhage |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
1/145 (0.69%)
|
1 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Small intestinal obstruction |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
2/124 (1.61%)
|
3 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Small intestinal perforation |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
1/124 (0.81%)
|
1 |
0/145 (0.00%)
|
0 |
1/21 (4.76%)
|
1 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Upper gastrointestinal haemorrhage |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
1/124 (0.81%)
|
1 |
1/145 (0.69%)
|
1 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Vomiting |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
3/124 (2.42%)
|
3 |
2/145 (1.38%)
|
2 |
0/21 (0.00%)
|
0 |
1/21 (4.76%)
|
1 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
General disorders |
|
|
|
|
|
|
|
|
|
Asthenia |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
2/124 (1.61%)
|
3 |
1/145 (0.69%)
|
1 |
1/21 (4.76%)
|
1 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
2/20 (10.00%)
|
3 |
0/1 (0.00%)
|
0 |
Chest pain |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
1/20 (5.00%)
|
1 |
0/1 (0.00%)
|
0 |
Fatigue |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
2/124 (1.61%)
|
2 |
1/145 (0.69%)
|
1 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
1/22 (4.55%)
|
1 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
General physical health deterioration |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
3/124 (2.42%)
|
5 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Non-cardiac chest pain |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
2/124 (1.61%)
|
2 |
1/145 (0.69%)
|
1 |
0/21 (0.00%)
|
0 |
1/21 (4.76%)
|
1 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Pain |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
1/145 (0.69%)
|
1 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Pyrexia |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
3/124 (2.42%)
|
3 |
2/145 (1.38%)
|
3 |
0/21 (0.00%)
|
0 |
1/21 (4.76%)
|
1 |
1/22 (4.55%)
|
1 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Sudden death |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
1/145 (0.69%)
|
1 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Hepatobiliary disorders |
|
|
|
|
|
|
|
|
|
Cholecystitis |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
3/145 (2.07%)
|
3 |
2/21 (9.52%)
|
2 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Cholecystitis acute |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
1/124 (0.81%)
|
1 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
1/21 (4.76%)
|
1 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Hepatic failure |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
2/145 (1.38%)
|
3 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Hepatitis |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
1/124 (0.81%)
|
1 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Immune-mediated hepatitis |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
1/145 (0.69%)
|
1 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Portal vein thrombosis |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
1/22 (4.55%)
|
2 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Immune system disorders |
|
|
|
|
|
|
|
|
|
Contrast media allergy |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
1/145 (0.69%)
|
1 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Infections and infestations |
|
|
|
|
|
|
|
|
|
Clostridial sepsis |
1/2 (50.00%)
|
1 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Abdominal infection |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
0/145 (0.00%)
|
0 |
1/21 (4.76%)
|
2 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Abscess limb |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
1/145 (0.69%)
|
1 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Abscess oral |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
1/22 (4.55%)
|
2 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Anorectal infection |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
1/145 (0.69%)
|
1 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Appendicitis |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
1/124 (0.81%)
|
1 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
COVID-19 pneumonia |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
2/124 (1.61%)
|
2 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Cellulitis |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
1/145 (0.69%)
|
1 |
0/21 (0.00%)
|
0 |
1/21 (4.76%)
|
1 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Diverticulitis |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
1/124 (0.81%)
|
1 |
3/145 (2.07%)
|
4 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Diverticulitis intestinal haemorrhagic |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
1/124 (0.81%)
|
1 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Enterocolitis infectious |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
0/145 (0.00%)
|
0 |
1/21 (4.76%)
|
1 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Epiglottitis |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
1/22 (4.55%)
|
1 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Escherichia sepsis |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
1/124 (0.81%)
|
2 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Groin infection |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
1/124 (0.81%)
|
1 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Infection |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
1/145 (0.69%)
|
2 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Influenza |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
1/124 (0.81%)
|
1 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Necrotising fasciitis |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
1/124 (0.81%)
|
1 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Pelvic abscess |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
1/124 (0.81%)
|
1 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Peritonitis |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
1/124 (0.81%)
|
1 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Pneumonia |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
1/124 (0.81%)
|
1 |
6/145 (4.14%)
|
8 |
0/21 (0.00%)
|
0 |
1/21 (4.76%)
|
2 |
1/22 (4.55%)
|
1 |
2/20 (10.00%)
|
3 |
0/1 (0.00%)
|
0 |
Post procedural infection |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
1/145 (0.69%)
|
1 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Psoas abscess |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
1/20 (5.00%)
|
1 |
0/1 (0.00%)
|
0 |
Pyelonephritis |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
1/124 (0.81%)
|
1 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
1/20 (5.00%)
|
1 |
0/1 (0.00%)
|
0 |
Rectal abscess |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
1/145 (0.69%)
|
1 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Respiratory tract infection |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
1/124 (0.81%)
|
1 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Sepsis |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
1/124 (0.81%)
|
2 |
3/145 (2.07%)
|
5 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
3/20 (15.00%)
|
5 |
0/1 (0.00%)
|
0 |
Staphylococcal sepsis |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
0/145 (0.00%)
|
0 |
1/21 (4.76%)
|
2 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Upper respiratory tract infection |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
0/145 (0.00%)
|
0 |
1/21 (4.76%)
|
1 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Urinary tract infection |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
3/124 (2.42%)
|
3 |
1/145 (0.69%)
|
1 |
1/21 (4.76%)
|
1 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
1/20 (5.00%)
|
1 |
0/1 (0.00%)
|
0 |
Urosepsis |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
1/20 (5.00%)
|
2 |
0/1 (0.00%)
|
0 |
Wound infection |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
1/145 (0.69%)
|
1 |
1/21 (4.76%)
|
1 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Injury, poisoning and procedural complications |
|
|
|
|
|
|
|
|
|
Hypobarism |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
1/145 (0.69%)
|
1 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Post procedural haemorrhage |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
0/145 (0.00%)
|
0 |
1/21 (4.76%)
|
1 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Post procedural oedema |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
1/145 (0.69%)
|
1 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Rib fracture |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
1/145 (0.69%)
|
1 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Spinal compression fracture |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
1/21 (4.76%)
|
3 |
1/22 (4.55%)
|
1 |
1/20 (5.00%)
|
2 |
0/1 (0.00%)
|
0 |
Thoracic vertebral fracture |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
1/124 (0.81%)
|
1 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Vascular pseudoaneurysm |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
1/22 (4.55%)
|
1 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Investigations |
|
|
|
|
|
|
|
|
|
Alanine aminotransferase increased |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
1/124 (0.81%)
|
1 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Amylase increased |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
1/124 (0.81%)
|
1 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Aspartate aminotransferase increased |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
1/124 (0.81%)
|
1 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Blood bilirubin increased |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
1/124 (0.81%)
|
1 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Blood creatinine increased |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
2/124 (1.61%)
|
2 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Lipase increased |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
1/124 (0.81%)
|
1 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Troponin increased |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
1/145 (0.69%)
|
1 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Metabolism and nutrition disorders |
|
|
|
|
|
|
|
|
|
Cachexia |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
1/145 (0.69%)
|
1 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Decreased appetite |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
2/124 (1.61%)
|
2 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Dehydration |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
2/124 (1.61%)
|
2 |
6/145 (4.14%)
|
7 |
1/21 (4.76%)
|
1 |
1/21 (4.76%)
|
1 |
1/22 (4.55%)
|
1 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Failure to thrive |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
2/124 (1.61%)
|
2 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
1/21 (4.76%)
|
1 |
1/22 (4.55%)
|
1 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Hypercalcaemia |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
1/145 (0.69%)
|
1 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Hyperglycaemia |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
1/145 (0.69%)
|
1 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Hyperkalaemia |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
1/124 (0.81%)
|
1 |
1/145 (0.69%)
|
1 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Hypoalbuminaemia |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
1/124 (0.81%)
|
1 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Hypocalcaemia |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
1/124 (0.81%)
|
1 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Hypomagnesaemia |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
1/124 (0.81%)
|
1 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Hyponatraemia |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
3/124 (2.42%)
|
3 |
3/145 (2.07%)
|
3 |
1/21 (4.76%)
|
1 |
1/21 (4.76%)
|
1 |
1/22 (4.55%)
|
1 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Metabolic acidosis |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
1/145 (0.69%)
|
1 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Musculoskeletal and connective tissue disorders |
|
|
|
|
|
|
|
|
|
Arthralgia |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
1/124 (0.81%)
|
1 |
1/145 (0.69%)
|
1 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Back pain |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
2/124 (1.61%)
|
3 |
2/145 (1.38%)
|
2 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Flank pain |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
1/124 (0.81%)
|
3 |
1/145 (0.69%)
|
1 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Muscular weakness |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
2/124 (1.61%)
|
2 |
1/145 (0.69%)
|
3 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Musculoskeletal pain |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
1/124 (0.81%)
|
1 |
1/145 (0.69%)
|
1 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Myopathy toxic |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
1/21 (4.76%)
|
1 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Pain in extremity |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
2/145 (1.38%)
|
2 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Pathological fracture |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
2/145 (1.38%)
|
2 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Rhabdomyolysis |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
1/145 (0.69%)
|
1 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
|
|
|
|
|
|
|
|
Acute myeloid leukaemia |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
1/20 (5.00%)
|
1 |
0/1 (0.00%)
|
0 |
Cancer pain |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
1/124 (0.81%)
|
1 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Intracranial tumour haemorrhage |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
1/145 (0.69%)
|
2 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Invasive ductal breast carcinoma |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
1/124 (0.81%)
|
1 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Malignant pleural effusion |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
1/145 (0.69%)
|
1 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Metastases to bone |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
1/145 (0.69%)
|
1 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Metastases to central nervous system |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
2/124 (1.61%)
|
2 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Squamous cell carcinoma of skin |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
1/124 (0.81%)
|
1 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Tumour associated fever |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
1/145 (0.69%)
|
1 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Nervous system disorders |
|
|
|
|
|
|
|
|
|
Encephalopathy |
0/2 (0.00%)
|
0 |
1/1 (100.00%)
|
1 |
3/124 (2.42%)
|
4 |
1/145 (0.69%)
|
1 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Cerebral ischaemia |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
1/124 (0.81%)
|
1 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Cognitive disorder |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
1/145 (0.69%)
|
1 |
0/21 (0.00%)
|
0 |
1/21 (4.76%)
|
1 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Dizziness |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
1/145 (0.69%)
|
1 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Dysarthria |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
1/124 (0.81%)
|
1 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Generalised tonic-clonic seizure |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
1/124 (0.81%)
|
1 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Haemorrhage intracranial |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
2/124 (1.61%)
|
3 |
1/145 (0.69%)
|
1 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Headache |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
1/124 (0.81%)
|
1 |
1/145 (0.69%)
|
1 |
1/21 (4.76%)
|
1 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Hydrocephalus |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
1/21 (4.76%)
|
1 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Hypertensive encephalopathy |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
1/20 (5.00%)
|
1 |
0/1 (0.00%)
|
0 |
Intraventricular haemorrhage |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
1/124 (0.81%)
|
1 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Metabolic encephalopathy |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
1/124 (0.81%)
|
2 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
1/21 (4.76%)
|
1 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Nervous system disorder |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
1/124 (0.81%)
|
1 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Peripheral sensory neuropathy |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
1/124 (0.81%)
|
1 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Posterior reversible encephalopathy syndrome |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
1/124 (0.81%)
|
1 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
1/21 (4.76%)
|
1 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Ruptured cerebral aneurysm |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
1/21 (4.76%)
|
1 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Seizure |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
1/124 (0.81%)
|
1 |
0/145 (0.00%)
|
0 |
2/21 (9.52%)
|
4 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Subarachnoid haemorrhage |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
1/145 (0.69%)
|
1 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Syncope |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
2/124 (1.61%)
|
2 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Transient ischaemic attack |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
3/124 (2.42%)
|
3 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Psychiatric disorders |
|
|
|
|
|
|
|
|
|
Confusional state |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
3/124 (2.42%)
|
3 |
1/145 (0.69%)
|
1 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Mental status changes |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
1/20 (5.00%)
|
1 |
0/1 (0.00%)
|
0 |
Renal and urinary disorders |
|
|
|
|
|
|
|
|
|
Acute kidney injury |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
1/124 (0.81%)
|
1 |
6/145 (4.14%)
|
7 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
1/22 (4.55%)
|
1 |
2/20 (10.00%)
|
2 |
0/1 (0.00%)
|
0 |
Autoimmune nephritis |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
2/124 (1.61%)
|
2 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Haematuria |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
1/145 (0.69%)
|
1 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
1/20 (5.00%)
|
1 |
0/1 (0.00%)
|
0 |
Hydronephrosis |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
2/124 (1.61%)
|
2 |
1/145 (0.69%)
|
1 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
1/20 (5.00%)
|
1 |
0/1 (0.00%)
|
0 |
Nephrolithiasis |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
1/145 (0.69%)
|
1 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Proteinuria |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
1/124 (0.81%)
|
1 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Renal failure |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
1/145 (0.69%)
|
1 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Renal impairment |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
1/124 (0.81%)
|
1 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Urinary retention |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
1/22 (4.55%)
|
1 |
1/20 (5.00%)
|
1 |
0/1 (0.00%)
|
0 |
Reproductive system and breast disorders |
|
|
|
|
|
|
|
|
|
Breast pain |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
1/124 (0.81%)
|
1 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Female genital tract fistula |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
1/124 (0.81%)
|
1 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Respiratory, thoracic and mediastinal disorders |
|
|
|
|
|
|
|
|
|
Acute respiratory failure |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
1/145 (0.69%)
|
2 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Aspiration |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
1/22 (4.55%)
|
1 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Atelectasis |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
1/145 (0.69%)
|
1 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Chronic obstructive pulmonary disease |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
2/21 (9.52%)
|
2 |
1/22 (4.55%)
|
1 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Cough |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
2/145 (1.38%)
|
2 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Dyspnoea |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
3/124 (2.42%)
|
3 |
6/145 (4.14%)
|
7 |
0/21 (0.00%)
|
0 |
2/21 (9.52%)
|
2 |
1/22 (4.55%)
|
1 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Epistaxis |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
1/124 (0.81%)
|
1 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
1/22 (4.55%)
|
1 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Haemoptysis |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
1/22 (4.55%)
|
1 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Hypoxia |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
2/145 (1.38%)
|
2 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
1/20 (5.00%)
|
1 |
0/1 (0.00%)
|
0 |
Immune-mediated pneumonitis |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
1/124 (0.81%)
|
1 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Laryngeal haemorrhage |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
1/22 (4.55%)
|
1 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Pharyngeal haemorrhage |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
1/22 (4.55%)
|
1 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Pharyngeal inflammation |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
1/145 (0.69%)
|
1 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Pleural effusion |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
4/124 (3.23%)
|
4 |
1/145 (0.69%)
|
1 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Pleuritic pain |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
1/124 (0.81%)
|
1 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Pneumonia aspiration |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
0/145 (0.00%)
|
0 |
1/21 (4.76%)
|
2 |
1/21 (4.76%)
|
2 |
0/22 (0.00%)
|
0 |
1/20 (5.00%)
|
2 |
0/1 (0.00%)
|
0 |
Pneumonitis |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
3/145 (2.07%)
|
3 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
1/22 (4.55%)
|
1 |
1/20 (5.00%)
|
1 |
0/1 (0.00%)
|
0 |
Pneumothorax |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
1/124 (0.81%)
|
2 |
2/145 (1.38%)
|
2 |
0/21 (0.00%)
|
0 |
1/21 (4.76%)
|
1 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Pneumothorax spontaneous |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
1/145 (0.69%)
|
1 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Pulmonary embolism |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
1/124 (0.81%)
|
1 |
3/145 (2.07%)
|
3 |
0/21 (0.00%)
|
0 |
1/21 (4.76%)
|
1 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Pulmonary haemorrhage |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
2/21 (9.52%)
|
3 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Pulmonary oedema |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
1/145 (0.69%)
|
1 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
1/22 (4.55%)
|
1 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Respiratory failure |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
1/22 (4.55%)
|
1 |
1/20 (5.00%)
|
1 |
0/1 (0.00%)
|
0 |
Skin and subcutaneous tissue disorders |
|
|
|
|
|
|
|
|
|
Drug eruption |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
1/21 (4.76%)
|
1 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Erythema |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
1/21 (4.76%)
|
1 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Skin ulcer |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
1/124 (0.81%)
|
1 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Rash maculo-papular |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
1/124 (0.81%)
|
1 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Vascular disorders |
|
|
|
|
|
|
|
|
|
Arteriosclerosis |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
0/145 (0.00%)
|
0 |
1/21 (4.76%)
|
1 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Deep vein thrombosis |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
2/124 (1.61%)
|
2 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Hypertension |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
8/124 (6.45%)
|
9 |
5/145 (3.45%)
|
5 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
2/22 (9.09%)
|
2 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Hypotension |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
1/124 (0.81%)
|
1 |
4/145 (2.76%)
|
5 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Term from vocabulary, MedDRA 23.0
Indicates events were collected by systematic assessment
|
|
Frequency Threshold for Reporting Other Adverse Events
|
0%
|
|
Phase 1b, Lenvatinib 24 mg/Day + Pembrolizumab 200 mg: RCC
|
Phase 1b, Lenvatinib 24 mg/Day + Pembrolizumab 200 mg: NSCLC
|
Phase 1b and 2, Lenvatinib 20 mg/Day+Pembrolizumab 200 mg: EC
|
Phase 1b and 2, Lenvatinib 20 mg/Day+Pembrolizumab 200 mg: RCC
|
Phase 1b and 2, Lenvatinib 20 mg/Day+Pembrolizumab 200 mg: Melanoma
|
Phase 1b and 2, Lenvatinib 20 mg/Day+Pembrolizumab 200 mg: NSCLC
|
Phase 1b and 2,Lenvatinib 20 mg/Day+Pembrolizumab 200 mg: HNSCC
|
Phase 1b and 2, Lenvatinib 20 mg/Day+Pembrolizumab 200 mg: UC
|
Phase1b and 2, Lenvatinib 20mg/Day+Pembrolizumab 200 mg: Leiomyosarcoma
|
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Total |
2/2 (100.00%)
|
|
1/1 (100.00%)
|
|
122/124 (98.39%)
|
|
145/145 (100.00%)
|
|
21/21 (100.00%)
|
|
21/21 (100.00%)
|
|
22/22 (100.00%)
|
|
20/20 (100.00%)
|
|
1/1 (100.00%)
|
|
Blood and lymphatic system disorders |
|
|
|
|
|
|
|
|
|
Anaemia |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
11/124 (8.87%)
|
16 |
19/145 (13.10%)
|
31 |
2/21 (9.52%)
|
4 |
3/21 (14.29%)
|
3 |
4/22 (18.18%)
|
5 |
6/20 (30.00%)
|
7 |
0/1 (0.00%)
|
0 |
Thrombocytopenia |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
9/124 (7.26%)
|
17 |
0/145 (0.00%)
|
0 |
1/21 (4.76%)
|
3 |
3/21 (14.29%)
|
4 |
1/22 (4.55%)
|
1 |
3/20 (15.00%)
|
4 |
0/1 (0.00%)
|
0 |
Cardiac disorders |
|
|
|
|
|
|
|
|
|
Atrioventricular block first degree |
1/2 (50.00%)
|
1 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Ventricular arrhythmia |
1/2 (50.00%)
|
1 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Arteriosclerosis coronary artery |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
1/21 (4.76%)
|
1 |
0/22 (0.00%)
|
0 |
3/20 (15.00%)
|
3 |
0/1 (0.00%)
|
0 |
Atrial fibrillation |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
1/124 (0.81%)
|
1 |
1/145 (0.69%)
|
1 |
2/21 (9.52%)
|
2 |
1/21 (4.76%)
|
1 |
0/22 (0.00%)
|
0 |
2/20 (10.00%)
|
2 |
0/1 (0.00%)
|
0 |
Bradycardia |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
1/124 (0.81%)
|
1 |
1/145 (0.69%)
|
1 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
2/20 (10.00%)
|
2 |
0/1 (0.00%)
|
0 |
Cardiac failure congestive |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
2/20 (10.00%)
|
2 |
0/1 (0.00%)
|
0 |
Palpitations |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
7/124 (5.65%)
|
10 |
4/145 (2.76%)
|
4 |
0/21 (0.00%)
|
0 |
1/21 (4.76%)
|
1 |
0/22 (0.00%)
|
0 |
2/20 (10.00%)
|
2 |
0/1 (0.00%)
|
0 |
Endocrine disorders |
|
|
|
|
|
|
|
|
|
Hypothyroidism |
1/2 (50.00%)
|
1 |
1/1 (100.00%)
|
1 |
61/124 (49.19%)
|
77 |
60/145 (41.38%)
|
66 |
7/21 (33.33%)
|
10 |
8/21 (38.10%)
|
8 |
6/22 (27.27%)
|
7 |
8/20 (40.00%)
|
8 |
0/1 (0.00%)
|
0 |
Adrenal insufficiency |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
2/124 (1.61%)
|
2 |
10/145 (6.90%)
|
10 |
1/21 (4.76%)
|
1 |
3/21 (14.29%)
|
6 |
2/22 (9.09%)
|
2 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Hyperthyroidism |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
7/124 (5.65%)
|
7 |
6/145 (4.14%)
|
7 |
2/21 (9.52%)
|
2 |
1/21 (4.76%)
|
1 |
1/22 (4.55%)
|
2 |
1/20 (5.00%)
|
1 |
0/1 (0.00%)
|
0 |
Eye disorders |
|
|
|
|
|
|
|
|
|
Vision blurred |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
5/124 (4.03%)
|
6 |
8/145 (5.52%)
|
8 |
1/21 (4.76%)
|
2 |
0/21 (0.00%)
|
0 |
1/22 (4.55%)
|
1 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Gastrointestinal disorders |
|
|
|
|
|
|
|
|
|
Abdominal distension |
1/2 (50.00%)
|
2 |
0/1 (0.00%)
|
0 |
10/124 (8.06%)
|
13 |
7/145 (4.83%)
|
8 |
2/21 (9.52%)
|
2 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
2/20 (10.00%)
|
2 |
0/1 (0.00%)
|
0 |
Constipation |
1/2 (50.00%)
|
1 |
0/1 (0.00%)
|
0 |
41/124 (33.06%)
|
50 |
43/145 (29.66%)
|
55 |
9/21 (42.86%)
|
14 |
7/21 (33.33%)
|
9 |
5/22 (22.73%)
|
5 |
5/20 (25.00%)
|
7 |
0/1 (0.00%)
|
0 |
Diarrhoea |
2/2 (100.00%)
|
4 |
1/1 (100.00%)
|
3 |
79/124 (63.71%)
|
270 |
97/145 (66.90%)
|
330 |
13/21 (61.90%)
|
23 |
12/21 (57.14%)
|
39 |
8/22 (36.36%)
|
26 |
11/20 (55.00%)
|
36 |
0/1 (0.00%)
|
0 |
Dyspepsia |
0/2 (0.00%)
|
0 |
1/1 (100.00%)
|
1 |
12/124 (9.68%)
|
13 |
21/145 (14.48%)
|
30 |
3/21 (14.29%)
|
3 |
1/21 (4.76%)
|
1 |
0/22 (0.00%)
|
0 |
2/20 (10.00%)
|
3 |
0/1 (0.00%)
|
0 |
Nausea |
2/2 (100.00%)
|
2 |
0/1 (0.00%)
|
0 |
66/124 (53.23%)
|
144 |
74/145 (51.03%)
|
132 |
13/21 (61.90%)
|
24 |
10/21 (47.62%)
|
18 |
9/22 (40.91%)
|
11 |
12/20 (60.00%)
|
19 |
0/1 (0.00%)
|
0 |
Stomatitis |
2/2 (100.00%)
|
4 |
1/1 (100.00%)
|
1 |
45/124 (36.29%)
|
79 |
63/145 (43.45%)
|
109 |
1/21 (4.76%)
|
1 |
5/21 (23.81%)
|
6 |
7/22 (31.82%)
|
13 |
2/20 (10.00%)
|
2 |
1/1 (100.00%)
|
1 |
Vomiting |
1/2 (50.00%)
|
2 |
0/1 (0.00%)
|
0 |
56/124 (45.16%)
|
137 |
44/145 (30.34%)
|
84 |
9/21 (42.86%)
|
13 |
8/21 (38.10%)
|
14 |
6/22 (27.27%)
|
7 |
10/20 (50.00%)
|
12 |
1/1 (100.00%)
|
1 |
Abdominal discomfort |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
2/124 (1.61%)
|
3 |
8/145 (5.52%)
|
11 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
1/22 (4.55%)
|
1 |
1/20 (5.00%)
|
1 |
0/1 (0.00%)
|
0 |
Abdominal pain |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
38/124 (30.65%)
|
58 |
37/145 (25.52%)
|
52 |
5/21 (23.81%)
|
5 |
5/21 (23.81%)
|
6 |
1/22 (4.55%)
|
2 |
3/20 (15.00%)
|
4 |
0/1 (0.00%)
|
0 |
Abdominal pain upper |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
12/124 (9.68%)
|
16 |
14/145 (9.66%)
|
24 |
0/21 (0.00%)
|
0 |
1/21 (4.76%)
|
1 |
0/22 (0.00%)
|
0 |
3/20 (15.00%)
|
3 |
0/1 (0.00%)
|
0 |
Anorectal discomfort |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
1/145 (0.69%)
|
1 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
2/20 (10.00%)
|
2 |
0/1 (0.00%)
|
0 |
Colitis |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
6/124 (4.84%)
|
6 |
5/145 (3.45%)
|
5 |
0/21 (0.00%)
|
0 |
2/21 (9.52%)
|
4 |
1/22 (4.55%)
|
1 |
2/20 (10.00%)
|
2 |
0/1 (0.00%)
|
0 |
Dry mouth |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
22/124 (17.74%)
|
30 |
20/145 (13.79%)
|
23 |
3/21 (14.29%)
|
3 |
3/21 (14.29%)
|
4 |
1/22 (4.55%)
|
1 |
3/20 (15.00%)
|
3 |
0/1 (0.00%)
|
0 |
Dysphagia |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
11/124 (8.87%)
|
15 |
5/145 (3.45%)
|
6 |
1/21 (4.76%)
|
1 |
2/21 (9.52%)
|
2 |
3/22 (13.64%)
|
5 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Flatulence |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
5/124 (4.03%)
|
5 |
15/145 (10.34%)
|
16 |
1/21 (4.76%)
|
1 |
1/21 (4.76%)
|
1 |
0/22 (0.00%)
|
0 |
1/20 (5.00%)
|
1 |
0/1 (0.00%)
|
0 |
Gastrooesophageal reflux disease |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
18/124 (14.52%)
|
21 |
9/145 (6.21%)
|
9 |
1/21 (4.76%)
|
1 |
1/21 (4.76%)
|
1 |
0/22 (0.00%)
|
0 |
2/20 (10.00%)
|
2 |
0/1 (0.00%)
|
0 |
Gingival bleeding |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
2/124 (1.61%)
|
2 |
8/145 (5.52%)
|
9 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Gingival pain |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
2/124 (1.61%)
|
2 |
5/145 (3.45%)
|
7 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
2/22 (9.09%)
|
3 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Haemorrhoids |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
9/124 (7.26%)
|
9 |
3/145 (2.07%)
|
3 |
1/21 (4.76%)
|
2 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
3/20 (15.00%)
|
3 |
0/1 (0.00%)
|
0 |
Oesophagitis |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
2/124 (1.61%)
|
2 |
2/145 (1.38%)
|
2 |
0/21 (0.00%)
|
0 |
2/21 (9.52%)
|
3 |
1/22 (4.55%)
|
1 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Oral pain |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
11/124 (8.87%)
|
15 |
11/145 (7.59%)
|
12 |
5/21 (23.81%)
|
6 |
1/21 (4.76%)
|
1 |
6/22 (27.27%)
|
22 |
1/20 (5.00%)
|
1 |
0/1 (0.00%)
|
0 |
Proctalgia |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
2/124 (1.61%)
|
3 |
3/145 (2.07%)
|
3 |
2/21 (9.52%)
|
2 |
1/21 (4.76%)
|
1 |
1/22 (4.55%)
|
1 |
1/20 (5.00%)
|
1 |
0/1 (0.00%)
|
0 |
Toothache |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
3/124 (2.42%)
|
6 |
13/145 (8.97%)
|
17 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
1/22 (4.55%)
|
1 |
1/20 (5.00%)
|
1 |
0/1 (0.00%)
|
0 |
Cheilitis |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
1/1 (100.00%)
|
1 |
General disorders |
|
|
|
|
|
|
|
|
|
Fatigue |
2/2 (100.00%)
|
6 |
1/1 (100.00%)
|
3 |
66/124 (53.23%)
|
159 |
95/145 (65.52%)
|
261 |
14/21 (66.67%)
|
21 |
15/21 (71.43%)
|
33 |
11/22 (50.00%)
|
25 |
12/20 (60.00%)
|
21 |
1/1 (100.00%)
|
1 |
Asthenia |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
22/124 (17.74%)
|
70 |
6/145 (4.14%)
|
12 |
1/21 (4.76%)
|
1 |
2/21 (9.52%)
|
3 |
1/22 (4.55%)
|
1 |
4/20 (20.00%)
|
6 |
0/1 (0.00%)
|
0 |
Chills |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
14/124 (11.29%)
|
16 |
11/145 (7.59%)
|
12 |
1/21 (4.76%)
|
2 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
2/20 (10.00%)
|
2 |
0/1 (0.00%)
|
0 |
Cyst |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
2/21 (9.52%)
|
2 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Gait disturbance |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
6/124 (4.84%)
|
6 |
0/145 (0.00%)
|
0 |
1/21 (4.76%)
|
1 |
2/21 (9.52%)
|
3 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Non-cardiac chest pain |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
8/124 (6.45%)
|
8 |
5/145 (3.45%)
|
5 |
0/21 (0.00%)
|
0 |
1/21 (4.76%)
|
1 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Oedema peripheral |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
29/124 (23.39%)
|
38 |
27/145 (18.62%)
|
37 |
5/21 (23.81%)
|
6 |
5/21 (23.81%)
|
12 |
3/22 (13.64%)
|
4 |
6/20 (30.00%)
|
16 |
0/1 (0.00%)
|
0 |
Pain |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
4/124 (3.23%)
|
6 |
15/145 (10.34%)
|
18 |
0/21 (0.00%)
|
0 |
1/21 (4.76%)
|
1 |
1/22 (4.55%)
|
1 |
1/20 (5.00%)
|
1 |
0/1 (0.00%)
|
0 |
Pyrexia |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
13/124 (10.48%)
|
16 |
21/145 (14.48%)
|
28 |
1/21 (4.76%)
|
1 |
0/21 (0.00%)
|
0 |
2/22 (9.09%)
|
2 |
2/20 (10.00%)
|
4 |
0/1 (0.00%)
|
0 |
Temperature intolerance |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
1/124 (0.81%)
|
1 |
10/145 (6.90%)
|
12 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Infections and infestations |
|
|
|
|
|
|
|
|
|
Gastroenteritis |
1/2 (50.00%)
|
1 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Osteomyelitis |
1/2 (50.00%)
|
1 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Skin infection |
2/2 (100.00%)
|
4 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Urinary tract infection |
0/2 (0.00%)
|
0 |
1/1 (100.00%)
|
1 |
37/124 (29.84%)
|
59 |
8/145 (5.52%)
|
19 |
6/21 (28.57%)
|
8 |
3/21 (14.29%)
|
5 |
2/22 (9.09%)
|
4 |
9/20 (45.00%)
|
14 |
0/1 (0.00%)
|
0 |
Bronchitis |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
2/124 (1.61%)
|
2 |
2/145 (1.38%)
|
2 |
0/21 (0.00%)
|
0 |
1/21 (4.76%)
|
1 |
0/22 (0.00%)
|
0 |
3/20 (15.00%)
|
3 |
0/1 (0.00%)
|
0 |
Herpes zoster |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
1/124 (0.81%)
|
1 |
1/145 (0.69%)
|
1 |
2/21 (9.52%)
|
2 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Nasopharyngitis |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
5/124 (4.03%)
|
5 |
2/145 (1.38%)
|
2 |
1/21 (4.76%)
|
1 |
2/21 (9.52%)
|
3 |
1/22 (4.55%)
|
2 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Oral candidiasis |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
6/124 (4.84%)
|
7 |
2/145 (1.38%)
|
2 |
0/21 (0.00%)
|
0 |
1/21 (4.76%)
|
1 |
3/22 (13.64%)
|
3 |
1/20 (5.00%)
|
1 |
0/1 (0.00%)
|
0 |
Pneumonia |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
1/124 (0.81%)
|
1 |
8/145 (5.52%)
|
8 |
0/21 (0.00%)
|
0 |
1/21 (4.76%)
|
1 |
1/22 (4.55%)
|
1 |
2/20 (10.00%)
|
2 |
0/1 (0.00%)
|
0 |
Sinusitis |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
8/124 (6.45%)
|
12 |
4/145 (2.76%)
|
4 |
1/21 (4.76%)
|
1 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Soft tissue infection |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
0/145 (0.00%)
|
0 |
2/21 (9.52%)
|
2 |
1/21 (4.76%)
|
1 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Tooth infection |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
4/124 (3.23%)
|
5 |
4/145 (2.76%)
|
6 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
2/22 (9.09%)
|
2 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Upper respiratory tract infection |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
14/124 (11.29%)
|
17 |
9/145 (6.21%)
|
9 |
6/21 (28.57%)
|
9 |
4/21 (19.05%)
|
4 |
2/22 (9.09%)
|
2 |
2/20 (10.00%)
|
4 |
0/1 (0.00%)
|
0 |
Injury, poisoning and procedural complications |
|
|
|
|
|
|
|
|
|
Contusion |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
2/124 (1.61%)
|
2 |
13/145 (8.97%)
|
16 |
2/21 (9.52%)
|
2 |
2/21 (9.52%)
|
2 |
0/22 (0.00%)
|
0 |
1/20 (5.00%)
|
1 |
0/1 (0.00%)
|
0 |
Fall |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
6/124 (4.84%)
|
7 |
8/145 (5.52%)
|
12 |
0/21 (0.00%)
|
0 |
2/21 (9.52%)
|
2 |
0/22 (0.00%)
|
0 |
4/20 (20.00%)
|
4 |
0/1 (0.00%)
|
0 |
Stoma site haemorrhage |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
2/20 (10.00%)
|
2 |
0/1 (0.00%)
|
0 |
Investigations |
|
|
|
|
|
|
|
|
|
Aspartate aminotransferase increased |
1/2 (50.00%)
|
3 |
0/1 (0.00%)
|
0 |
15/124 (12.10%)
|
28 |
18/145 (12.41%)
|
33 |
3/21 (14.29%)
|
5 |
1/21 (4.76%)
|
4 |
2/22 (9.09%)
|
5 |
3/20 (15.00%)
|
5 |
0/1 (0.00%)
|
0 |
Liver function test increased |
1/2 (50.00%)
|
1 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Weight decreased |
1/2 (50.00%)
|
1 |
0/1 (0.00%)
|
0 |
45/124 (36.29%)
|
103 |
46/145 (31.72%)
|
79 |
5/21 (23.81%)
|
13 |
7/21 (33.33%)
|
21 |
5/22 (22.73%)
|
6 |
6/20 (30.00%)
|
9 |
0/1 (0.00%)
|
0 |
Alanine aminotransferase increased |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
17/124 (13.71%)
|
37 |
18/145 (12.41%)
|
35 |
3/21 (14.29%)
|
5 |
2/21 (9.52%)
|
4 |
1/22 (4.55%)
|
1 |
1/20 (5.00%)
|
1 |
0/1 (0.00%)
|
0 |
Amylase increased |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
7/124 (5.65%)
|
20 |
20/145 (13.79%)
|
67 |
0/21 (0.00%)
|
0 |
1/21 (4.76%)
|
1 |
0/22 (0.00%)
|
0 |
1/20 (5.00%)
|
3 |
0/1 (0.00%)
|
0 |
Blood alkaline phosphatase increased |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
14/124 (11.29%)
|
21 |
17/145 (11.72%)
|
31 |
2/21 (9.52%)
|
4 |
1/21 (4.76%)
|
2 |
1/22 (4.55%)
|
1 |
2/20 (10.00%)
|
2 |
0/1 (0.00%)
|
0 |
Blood bilirubin increased |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
9/124 (7.26%)
|
12 |
7/145 (4.83%)
|
7 |
1/21 (4.76%)
|
2 |
1/21 (4.76%)
|
1 |
0/22 (0.00%)
|
0 |
1/20 (5.00%)
|
1 |
0/1 (0.00%)
|
0 |
Blood cholesterol increased |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
6/124 (4.84%)
|
8 |
9/145 (6.21%)
|
14 |
0/21 (0.00%)
|
0 |
1/21 (4.76%)
|
1 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Blood creatinine increased |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
13/124 (10.48%)
|
26 |
29/145 (20.00%)
|
71 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
1/22 (4.55%)
|
1 |
1/20 (5.00%)
|
1 |
0/1 (0.00%)
|
0 |
Blood lactate dehydrogenase increased |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
8/145 (5.52%)
|
8 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Blood thyroid stimulating hormone increased |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
3/124 (2.42%)
|
3 |
12/145 (8.28%)
|
15 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
2/22 (9.09%)
|
2 |
1/20 (5.00%)
|
1 |
0/1 (0.00%)
|
0 |
Electrocardiogram QT prolonged |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
8/124 (6.45%)
|
9 |
6/145 (4.14%)
|
11 |
1/21 (4.76%)
|
1 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
2/20 (10.00%)
|
2 |
0/1 (0.00%)
|
0 |
Lipase increased |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
20/124 (16.13%)
|
44 |
32/145 (22.07%)
|
114 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
4/20 (20.00%)
|
18 |
0/1 (0.00%)
|
0 |
Lymphocyte count decreased |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
3/124 (2.42%)
|
4 |
4/145 (2.76%)
|
11 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
2/22 (9.09%)
|
3 |
1/20 (5.00%)
|
1 |
0/1 (0.00%)
|
0 |
Neutrophil count decreased |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
2/124 (1.61%)
|
2 |
1/145 (0.69%)
|
2 |
0/21 (0.00%)
|
0 |
2/21 (9.52%)
|
2 |
1/22 (4.55%)
|
6 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Platelet count decreased |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
5/124 (4.03%)
|
7 |
7/145 (4.83%)
|
9 |
1/21 (4.76%)
|
1 |
1/21 (4.76%)
|
3 |
2/22 (9.09%)
|
3 |
1/20 (5.00%)
|
1 |
0/1 (0.00%)
|
0 |
Metabolism and nutrition disorders |
|
|
|
|
|
|
|
|
|
Decreased appetite |
2/2 (100.00%)
|
3 |
1/1 (100.00%)
|
1 |
68/124 (54.84%)
|
135 |
70/145 (48.28%)
|
114 |
10/21 (47.62%)
|
15 |
16/21 (76.19%)
|
30 |
10/22 (45.45%)
|
14 |
10/20 (50.00%)
|
18 |
0/1 (0.00%)
|
0 |
Hypomagnesaemia |
1/2 (50.00%)
|
1 |
0/1 (0.00%)
|
0 |
35/124 (28.23%)
|
65 |
20/145 (13.79%)
|
44 |
1/21 (4.76%)
|
1 |
4/21 (19.05%)
|
4 |
2/22 (9.09%)
|
2 |
2/20 (10.00%)
|
6 |
0/1 (0.00%)
|
0 |
Hyponatraemia |
1/2 (50.00%)
|
1 |
0/1 (0.00%)
|
0 |
15/124 (12.10%)
|
21 |
21/145 (14.48%)
|
47 |
2/21 (9.52%)
|
2 |
5/21 (23.81%)
|
9 |
4/22 (18.18%)
|
10 |
4/20 (20.00%)
|
6 |
0/1 (0.00%)
|
0 |
Dehydration |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
17/124 (13.71%)
|
23 |
11/145 (7.59%)
|
17 |
3/21 (14.29%)
|
3 |
4/21 (19.05%)
|
8 |
1/22 (4.55%)
|
1 |
10/20 (50.00%)
|
12 |
0/1 (0.00%)
|
0 |
Electrolyte imbalance |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
0/145 (0.00%)
|
0 |
2/21 (9.52%)
|
2 |
1/21 (4.76%)
|
1 |
1/22 (4.55%)
|
1 |
2/20 (10.00%)
|
2 |
0/1 (0.00%)
|
0 |
Hypercalcaemia |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
2/124 (1.61%)
|
2 |
11/145 (7.59%)
|
13 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
1/20 (5.00%)
|
1 |
0/1 (0.00%)
|
0 |
Hyperglycaemia |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
8/124 (6.45%)
|
10 |
11/145 (7.59%)
|
12 |
2/21 (9.52%)
|
2 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
1/20 (5.00%)
|
1 |
0/1 (0.00%)
|
0 |
Hyperkalaemia |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
1/124 (0.81%)
|
1 |
15/145 (10.34%)
|
32 |
1/21 (4.76%)
|
2 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
1/20 (5.00%)
|
1 |
0/1 (0.00%)
|
0 |
Hypertriglyceridaemia |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
6/124 (4.84%)
|
11 |
29/145 (20.00%)
|
102 |
1/21 (4.76%)
|
1 |
1/21 (4.76%)
|
1 |
2/22 (9.09%)
|
4 |
2/20 (10.00%)
|
7 |
0/1 (0.00%)
|
0 |
Hypoalbuminaemia |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
8/124 (6.45%)
|
8 |
2/145 (1.38%)
|
5 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
1/22 (4.55%)
|
1 |
7/20 (35.00%)
|
13 |
0/1 (0.00%)
|
0 |
Hypocalcaemia |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
2/124 (1.61%)
|
3 |
4/145 (2.76%)
|
4 |
1/21 (4.76%)
|
1 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
4/20 (20.00%)
|
7 |
0/1 (0.00%)
|
0 |
Hypokalaemia |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
19/124 (15.32%)
|
33 |
10/145 (6.90%)
|
12 |
5/21 (23.81%)
|
5 |
5/21 (23.81%)
|
8 |
1/22 (4.55%)
|
1 |
2/20 (10.00%)
|
3 |
0/1 (0.00%)
|
0 |
Hypophosphataemia |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
3/124 (2.42%)
|
3 |
12/145 (8.28%)
|
16 |
4/21 (19.05%)
|
5 |
1/21 (4.76%)
|
1 |
0/22 (0.00%)
|
0 |
2/20 (10.00%)
|
2 |
0/1 (0.00%)
|
0 |
Musculoskeletal and connective tissue disorders |
|
|
|
|
|
|
|
|
|
Arthralgia |
0/2 (0.00%)
|
0 |
1/1 (100.00%)
|
2 |
49/124 (39.52%)
|
99 |
70/145 (48.28%)
|
123 |
7/21 (33.33%)
|
9 |
8/21 (38.10%)
|
16 |
4/22 (18.18%)
|
4 |
7/20 (35.00%)
|
8 |
0/1 (0.00%)
|
0 |
Back pain |
1/2 (50.00%)
|
2 |
0/1 (0.00%)
|
0 |
25/124 (20.16%)
|
38 |
36/145 (24.83%)
|
47 |
3/21 (14.29%)
|
4 |
4/21 (19.05%)
|
6 |
3/22 (13.64%)
|
3 |
5/20 (25.00%)
|
5 |
0/1 (0.00%)
|
0 |
Myalgia |
1/2 (50.00%)
|
1 |
0/1 (0.00%)
|
0 |
28/124 (22.58%)
|
39 |
20/145 (13.79%)
|
39 |
3/21 (14.29%)
|
3 |
1/21 (4.76%)
|
1 |
1/22 (4.55%)
|
1 |
3/20 (15.00%)
|
3 |
0/1 (0.00%)
|
0 |
Bone pain |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
2/124 (1.61%)
|
2 |
3/145 (2.07%)
|
4 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
2/20 (10.00%)
|
2 |
0/1 (0.00%)
|
0 |
Flank pain |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
5/124 (4.03%)
|
5 |
10/145 (6.90%)
|
17 |
1/21 (4.76%)
|
1 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
2/20 (10.00%)
|
6 |
0/1 (0.00%)
|
0 |
Muscle spasms |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
13/124 (10.48%)
|
18 |
17/145 (11.72%)
|
24 |
2/21 (9.52%)
|
2 |
1/21 (4.76%)
|
3 |
2/22 (9.09%)
|
3 |
3/20 (15.00%)
|
3 |
0/1 (0.00%)
|
0 |
Muscular weakness |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
13/124 (10.48%)
|
14 |
13/145 (8.97%)
|
15 |
4/21 (19.05%)
|
4 |
5/21 (23.81%)
|
6 |
1/22 (4.55%)
|
1 |
4/20 (20.00%)
|
4 |
0/1 (0.00%)
|
0 |
Musculoskeletal chest pain |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
4/124 (3.23%)
|
4 |
8/145 (5.52%)
|
12 |
1/21 (4.76%)
|
1 |
1/21 (4.76%)
|
1 |
2/22 (9.09%)
|
3 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Musculoskeletal pain |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
20/124 (16.13%)
|
26 |
20/145 (13.79%)
|
31 |
2/21 (9.52%)
|
3 |
3/21 (14.29%)
|
4 |
1/22 (4.55%)
|
2 |
1/20 (5.00%)
|
1 |
0/1 (0.00%)
|
0 |
Neck pain |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
6/124 (4.84%)
|
8 |
8/145 (5.52%)
|
8 |
1/21 (4.76%)
|
2 |
1/21 (4.76%)
|
1 |
2/22 (9.09%)
|
2 |
1/20 (5.00%)
|
1 |
0/1 (0.00%)
|
0 |
Pain in extremity |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
15/124 (12.10%)
|
20 |
28/145 (19.31%)
|
49 |
4/21 (19.05%)
|
4 |
4/21 (19.05%)
|
6 |
1/22 (4.55%)
|
1 |
4/20 (20.00%)
|
5 |
0/1 (0.00%)
|
0 |
Nervous system disorders |
|
|
|
|
|
|
|
|
|
Dizziness |
0/2 (0.00%)
|
0 |
1/1 (100.00%)
|
1 |
19/124 (15.32%)
|
24 |
30/145 (20.69%)
|
38 |
3/21 (14.29%)
|
4 |
6/21 (28.57%)
|
6 |
4/22 (18.18%)
|
4 |
2/20 (10.00%)
|
2 |
0/1 (0.00%)
|
0 |
Headache |
0/2 (0.00%)
|
0 |
1/1 (100.00%)
|
2 |
42/124 (33.87%)
|
62 |
44/145 (30.34%)
|
65 |
5/21 (23.81%)
|
6 |
2/21 (9.52%)
|
3 |
6/22 (27.27%)
|
8 |
4/20 (20.00%)
|
4 |
0/1 (0.00%)
|
0 |
Dizziness postural |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
2/21 (9.52%)
|
2 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Dysgeusia |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
14/124 (11.29%)
|
19 |
20/145 (13.79%)
|
24 |
0/21 (0.00%)
|
0 |
1/21 (4.76%)
|
1 |
1/22 (4.55%)
|
1 |
2/20 (10.00%)
|
2 |
0/1 (0.00%)
|
0 |
Lethargy |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
2/145 (1.38%)
|
2 |
2/21 (9.52%)
|
2 |
0/21 (0.00%)
|
0 |
1/22 (4.55%)
|
1 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Metabolic encephalopathy |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
2/20 (10.00%)
|
2 |
0/1 (0.00%)
|
0 |
Peripheral sensory neuropathy |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
11/124 (8.87%)
|
12 |
10/145 (6.90%)
|
11 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
3/22 (13.64%)
|
3 |
1/20 (5.00%)
|
1 |
0/1 (0.00%)
|
0 |
Somnolence |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
4/124 (3.23%)
|
5 |
1/145 (0.69%)
|
1 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
2/20 (10.00%)
|
2 |
0/1 (0.00%)
|
0 |
Tremor |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
3/124 (2.42%)
|
6 |
3/145 (2.07%)
|
3 |
0/21 (0.00%)
|
0 |
3/21 (14.29%)
|
5 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Psychiatric disorders |
|
|
|
|
|
|
|
|
|
Anxiety |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
9/124 (7.26%)
|
10 |
11/145 (7.59%)
|
11 |
0/21 (0.00%)
|
0 |
5/21 (23.81%)
|
6 |
2/22 (9.09%)
|
2 |
2/20 (10.00%)
|
3 |
0/1 (0.00%)
|
0 |
Confusional state |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
5/124 (4.03%)
|
6 |
2/145 (1.38%)
|
2 |
0/21 (0.00%)
|
0 |
3/21 (14.29%)
|
4 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Depression |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
9/124 (7.26%)
|
10 |
5/145 (3.45%)
|
5 |
1/21 (4.76%)
|
2 |
3/21 (14.29%)
|
5 |
1/22 (4.55%)
|
1 |
3/20 (15.00%)
|
3 |
0/1 (0.00%)
|
0 |
Insomnia |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
14/124 (11.29%)
|
18 |
24/145 (16.55%)
|
29 |
4/21 (19.05%)
|
4 |
3/21 (14.29%)
|
3 |
2/22 (9.09%)
|
2 |
4/20 (20.00%)
|
7 |
0/1 (0.00%)
|
0 |
Mental status changes |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
1/124 (0.81%)
|
1 |
0/145 (0.00%)
|
0 |
1/21 (4.76%)
|
1 |
1/21 (4.76%)
|
1 |
1/22 (4.55%)
|
2 |
3/20 (15.00%)
|
3 |
0/1 (0.00%)
|
0 |
Renal and urinary disorders |
|
|
|
|
|
|
|
|
|
Proteinuria |
1/2 (50.00%)
|
1 |
1/1 (100.00%)
|
2 |
37/124 (29.84%)
|
121 |
67/145 (46.21%)
|
168 |
7/21 (33.33%)
|
13 |
8/21 (38.10%)
|
23 |
5/22 (22.73%)
|
20 |
13/20 (65.00%)
|
38 |
0/1 (0.00%)
|
0 |
Dysuria |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
7/124 (5.65%)
|
8 |
4/145 (2.76%)
|
5 |
0/21 (0.00%)
|
0 |
1/21 (4.76%)
|
1 |
2/22 (9.09%)
|
4 |
1/20 (5.00%)
|
1 |
0/1 (0.00%)
|
0 |
Haematuria |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
4/124 (3.23%)
|
8 |
12/145 (8.28%)
|
16 |
1/21 (4.76%)
|
1 |
1/21 (4.76%)
|
1 |
0/22 (0.00%)
|
0 |
3/20 (15.00%)
|
3 |
0/1 (0.00%)
|
0 |
Hydronephrosis |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
3/124 (2.42%)
|
3 |
1/145 (0.69%)
|
1 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
2/20 (10.00%)
|
2 |
0/1 (0.00%)
|
0 |
Nocturia |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
9/145 (6.21%)
|
9 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Pollakiuria |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
6/124 (4.84%)
|
7 |
11/145 (7.59%)
|
11 |
1/21 (4.76%)
|
1 |
0/21 (0.00%)
|
0 |
1/22 (4.55%)
|
4 |
1/20 (5.00%)
|
3 |
0/1 (0.00%)
|
0 |
Urinary retention |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
3/145 (2.07%)
|
3 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
3/20 (15.00%)
|
3 |
0/1 (0.00%)
|
0 |
Reproductive system and breast disorders |
|
|
|
|
|
|
|
|
|
Pelvic pain |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
6/124 (4.84%)
|
6 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
4/20 (20.00%)
|
4 |
0/1 (0.00%)
|
0 |
Vaginal discharge |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
10/124 (8.06%)
|
10 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Respiratory, thoracic and mediastinal disorders |
|
|
|
|
|
|
|
|
|
Dysphonia |
2/2 (100.00%)
|
4 |
1/1 (100.00%)
|
1 |
37/124 (29.84%)
|
62 |
59/145 (40.69%)
|
78 |
10/21 (47.62%)
|
12 |
5/21 (23.81%)
|
9 |
6/22 (27.27%)
|
6 |
3/20 (15.00%)
|
3 |
0/1 (0.00%)
|
0 |
Hiccups |
1/2 (50.00%)
|
1 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Nasal congestion |
1/2 (50.00%)
|
1 |
0/1 (0.00%)
|
0 |
9/124 (7.26%)
|
10 |
28/145 (19.31%)
|
41 |
0/21 (0.00%)
|
0 |
1/21 (4.76%)
|
1 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Cough |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
33/124 (26.61%)
|
44 |
67/145 (46.21%)
|
103 |
4/21 (19.05%)
|
5 |
5/21 (23.81%)
|
8 |
7/22 (31.82%)
|
8 |
6/20 (30.00%)
|
13 |
0/1 (0.00%)
|
0 |
Dyspnoea |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
22/124 (17.74%)
|
26 |
43/145 (29.66%)
|
68 |
3/21 (14.29%)
|
3 |
8/21 (38.10%)
|
17 |
4/22 (18.18%)
|
6 |
8/20 (40.00%)
|
11 |
0/1 (0.00%)
|
0 |
Dyspnoea exertional |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
3/124 (2.42%)
|
3 |
2/145 (1.38%)
|
2 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
2/22 (9.09%)
|
2 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Epistaxis |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
13/124 (10.48%)
|
21 |
21/145 (14.48%)
|
32 |
2/21 (9.52%)
|
2 |
3/21 (14.29%)
|
4 |
1/22 (4.55%)
|
3 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Haemoptysis |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
2/145 (1.38%)
|
2 |
0/21 (0.00%)
|
0 |
1/21 (4.76%)
|
1 |
4/22 (18.18%)
|
5 |
1/20 (5.00%)
|
1 |
0/1 (0.00%)
|
0 |
Hypoxia |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
2/145 (1.38%)
|
3 |
0/21 (0.00%)
|
0 |
3/21 (14.29%)
|
3 |
1/22 (4.55%)
|
1 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Oropharyngeal pain |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
9/124 (7.26%)
|
12 |
24/145 (16.55%)
|
31 |
7/21 (33.33%)
|
7 |
3/21 (14.29%)
|
3 |
7/22 (31.82%)
|
21 |
2/20 (10.00%)
|
2 |
0/1 (0.00%)
|
0 |
Pleural effusion |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
2/124 (1.61%)
|
2 |
7/145 (4.83%)
|
8 |
0/21 (0.00%)
|
0 |
4/21 (19.05%)
|
5 |
1/22 (4.55%)
|
1 |
3/20 (15.00%)
|
40 |
0/1 (0.00%)
|
0 |
Productive cough |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
3/145 (2.07%)
|
3 |
1/21 (4.76%)
|
1 |
2/21 (9.52%)
|
3 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Rhinitis allergic |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
1/124 (0.81%)
|
1 |
8/145 (5.52%)
|
8 |
0/21 (0.00%)
|
0 |
1/21 (4.76%)
|
1 |
1/22 (4.55%)
|
1 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Rhinorrhoea |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
27/145 (18.62%)
|
47 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
1/20 (5.00%)
|
1 |
0/1 (0.00%)
|
0 |
Sneezing |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
13/145 (8.97%)
|
15 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Upper-airway cough syndrome |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
10/145 (6.90%)
|
11 |
1/21 (4.76%)
|
1 |
1/21 (4.76%)
|
1 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Wheezing |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
3/124 (2.42%)
|
3 |
4/145 (2.76%)
|
5 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
1/22 (4.55%)
|
1 |
2/20 (10.00%)
|
2 |
0/1 (0.00%)
|
0 |
Skin and subcutaneous tissue disorders |
|
|
|
|
|
|
|
|
|
Night sweats |
1/2 (50.00%)
|
1 |
0/1 (0.00%)
|
0 |
1/124 (0.81%)
|
1 |
8/145 (5.52%)
|
13 |
3/21 (14.29%)
|
3 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Skin ulcer |
1/2 (50.00%)
|
2 |
0/1 (0.00%)
|
0 |
4/124 (3.23%)
|
5 |
2/145 (1.38%)
|
3 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
2/22 (9.09%)
|
2 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Alopecia |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
11/124 (8.87%)
|
12 |
4/145 (2.76%)
|
5 |
3/21 (14.29%)
|
3 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Dermatitis acneiform |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
4/124 (3.23%)
|
4 |
11/145 (7.59%)
|
12 |
1/21 (4.76%)
|
1 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
1/20 (5.00%)
|
1 |
0/1 (0.00%)
|
0 |
Dry skin |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
15/124 (12.10%)
|
16 |
26/145 (17.93%)
|
33 |
0/21 (0.00%)
|
0 |
1/21 (4.76%)
|
1 |
3/22 (13.64%)
|
3 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Erythema |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
5/124 (4.03%)
|
6 |
8/145 (5.52%)
|
8 |
0/21 (0.00%)
|
0 |
1/21 (4.76%)
|
1 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Palmar-plantar erythrodysaesthesia syndrome |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
34/124 (27.42%)
|
80 |
46/145 (31.72%)
|
112 |
4/21 (19.05%)
|
5 |
0/21 (0.00%)
|
0 |
4/22 (18.18%)
|
7 |
2/20 (10.00%)
|
2 |
0/1 (0.00%)
|
0 |
Pruritus |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
19/124 (15.32%)
|
22 |
21/145 (14.48%)
|
28 |
1/21 (4.76%)
|
1 |
6/21 (28.57%)
|
13 |
2/22 (9.09%)
|
2 |
2/20 (10.00%)
|
4 |
0/1 (0.00%)
|
0 |
Rash |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
10/124 (8.06%)
|
22 |
25/145 (17.24%)
|
37 |
3/21 (14.29%)
|
3 |
3/21 (14.29%)
|
6 |
2/22 (9.09%)
|
2 |
4/20 (20.00%)
|
12 |
0/1 (0.00%)
|
0 |
Rash erythematous |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
4/145 (2.76%)
|
5 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
2/20 (10.00%)
|
3 |
0/1 (0.00%)
|
0 |
Rash maculo-papular |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
20/124 (16.13%)
|
36 |
25/145 (17.24%)
|
44 |
5/21 (23.81%)
|
6 |
1/21 (4.76%)
|
2 |
2/22 (9.09%)
|
2 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Rash pruritic |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
1/124 (0.81%)
|
1 |
2/145 (1.38%)
|
2 |
1/21 (4.76%)
|
1 |
2/21 (9.52%)
|
2 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Skin exfoliation |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
0/124 (0.00%)
|
0 |
0/145 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
2/22 (9.09%)
|
2 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Skin lesion |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
1/124 (0.81%)
|
1 |
2/145 (1.38%)
|
2 |
2/21 (9.52%)
|
3 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Vascular disorders |
|
|
|
|
|
|
|
|
|
Hypertension |
2/2 (100.00%)
|
2 |
1/1 (100.00%)
|
2 |
75/124 (60.48%)
|
173 |
66/145 (45.52%)
|
175 |
9/21 (42.86%)
|
12 |
8/21 (38.10%)
|
25 |
8/22 (36.36%)
|
16 |
9/20 (45.00%)
|
15 |
1/1 (100.00%)
|
2 |
Deep vein thrombosis |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
3/124 (2.42%)
|
3 |
1/145 (0.69%)
|
1 |
0/21 (0.00%)
|
0 |
2/21 (9.52%)
|
3 |
0/22 (0.00%)
|
0 |
2/20 (10.00%)
|
2 |
0/1 (0.00%)
|
0 |
Flushing |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
2/124 (1.61%)
|
3 |
1/145 (0.69%)
|
1 |
2/21 (9.52%)
|
2 |
1/21 (4.76%)
|
1 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Hypotension |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
10/124 (8.06%)
|
13 |
12/145 (8.28%)
|
13 |
1/21 (4.76%)
|
1 |
1/21 (4.76%)
|
1 |
3/22 (13.64%)
|
3 |
1/20 (5.00%)
|
1 |
0/1 (0.00%)
|
0 |
Peripheral embolism |
0/2 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
1/124 (0.81%)
|
1 |
2/145 (1.38%)
|
2 |
0/21 (0.00%)
|
0 |
0/21 (0.00%)
|
0 |
0/22 (0.00%)
|
0 |
0/20 (0.00%)
|
0 |
0/1 (0.00%)
|
0 |
Term from vocabulary, MedDRA 23.0
Indicates events were collected by systematic assessment
|