NCT03517449 · ADVERSE EVENTS
Adverse events
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.
- Collection time frame
- Up to approximately 79 months
- Other-event reporting threshold
- 5%
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
| Safety group | Serious events | Other events | Deaths |
|---|---|---|---|
| First Course: Lenvatinib + Pembrolizumab | 237 / 406 | 404 / 406 | 317 / 406 |
| First Course: TPC Doxorubicin or Paclitaxel | 121 / 388 | 379 / 388 | 362 / 388 |
| Second Course: Lenvatinib + Pembrolizumab | 4 / 21 | 20 / 21 | 8 / 21 |
| TPC Crossover | 1 / 6 | 6 / 6 | 1 / 6 |
Serious adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 27.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 406
- num Events
- 1
- group Id
- EG001
- num Affected
- 9
- num At Risk
- 388
- num Events
- 9
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- term
- Anaemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 27.1
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 406
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 388
- num Events
- 1
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- term
- Febrile bone marrow aplasia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 27.1
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 406
- num Events
- 2
- group Id
- EG001
- num Affected
- 16
- num At Risk
- 388
- num Events
- 17
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- term
- Febrile neutropenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 27.1
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 406
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 388
- num Events
- 1
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- term
- Leukocytosis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 27.1
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 406
- num Events
- 0
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 388
- num Events
- 2
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- term
- Leukopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 27.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 406
- num Events
- 1
- group Id
- EG001
- num Affected
- 8
- num At Risk
- 388
- num Events
- 8
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- term
- Neutropenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 27.1
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 406
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 388
- num Events
- 1
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- term
- Neutrophilia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 27.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 406
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 388
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- term
- Pancytopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 27.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 406
- num Events
- 1
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 388
- num Events
- 1
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- term
- Thrombocytopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 27.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 406
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 388
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- term
- Thrombotic microangiopathy
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA 27.1
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 406
- num Events
- 2
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 388
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- term
- Acute coronary syndrome
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA 27.1
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 406
- num Events
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 388
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- term
- Acute myocardial infarction
Other reported adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 27.1
- stats
- group Id
- EG000
- num Affected
- 115
- num At Risk
- 406
- num Events
- 171
- group Id
- EG001
- num Affected
- 181
- num At Risk
- 388
- num Events
- 240
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 21
- num Events
- 1
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 6
- num Events
- 3
- term
- Anaemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 27.1
- stats
- group Id
- EG000
- num Affected
- 28
- num At Risk
- 406
- num Events
- 72
- group Id
- EG001
- num Affected
- 50
- num At Risk
- 388
- num Events
- 89
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 21
- num Events
- 3
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- term
- Leukopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 27.1
- stats
- group Id
- EG000
- num Affected
- 26
- num At Risk
- 406
- num Events
- 61
- group Id
- EG001
- num Affected
- 30
- num At Risk
- 388
- num Events
- 45
- group Id
- EG002
- num Affected
- 2
- num At Risk
- 21
- num Events
- 5
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 6
- num Events
- 1
- term
- Lymphopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 27.1
- stats
- group Id
- EG000
- num Affected
- 38
- num At Risk
- 406
- num Events
- 106
- group Id
- EG001
- num Affected
- 125
- num At Risk
- 388
- num Events
- 213
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 21
- num Events
- 3
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- term
- Neutropenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 27.1
- stats
- group Id
- EG000
- num Affected
- 46
- num At Risk
- 406
- num Events
- 66
- group Id
- EG001
- num Affected
- 26
- num At Risk
- 388
- num Events
- 31
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- group Id
- EG003
- num Affected
- 2
- num At Risk
- 6
- num Events
- 3
- term
- Thrombocytopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Endocrine disorders
- source Vocabulary
- MedDRA 27.1
- stats
- group Id
- EG000
- num Affected
- 46
- num At Risk
- 406
- num Events
- 50
- group Id
- EG001
- num Affected
- 4
- num At Risk
- 388
- num Events
- 4
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 21
- num Events
- 1
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 6
- num Events
- 1
- term
- Hyperthyroidism
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Endocrine disorders
- source Vocabulary
- MedDRA 27.1
- stats
- group Id
- EG000
- num Affected
- 238
- num At Risk
- 406
- num Events
- 299
- group Id
- EG001
- num Affected
- 3
- num At Risk
- 388
- num Events
- 3
- group Id
- EG002
- num Affected
- 4
- num At Risk
- 21
- num Events
- 5
- group Id
- EG003
- num Affected
- 4
- num At Risk
- 6
- num Events
- 4
- term
- Hypothyroidism
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 27.1
- stats
- group Id
- EG000
- num Affected
- 96
- num At Risk
- 406
- num Events
- 141
- group Id
- EG001
- num Affected
- 52
- num At Risk
- 388
- num Events
- 58
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 6
- num Events
- 1
- term
- Abdominal pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 27.1
- stats
- group Id
- EG000
- num Affected
- 57
- num At Risk
- 406
- num Events
- 75
- group Id
- EG001
- num Affected
- 28
- num At Risk
- 388
- num Events
- 34
- group Id
- EG002
- num Affected
- 3
- num At Risk
- 21
- num Events
- 3
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 6
- num Events
- 1
- term
- Abdominal pain upper
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 27.1
- stats
- group Id
- EG000
- num Affected
- 116
- num At Risk
- 406
- num Events
- 142
- group Id
- EG001
- num Affected
- 95
- num At Risk
- 388
- num Events
- 119
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- group Id
- EG003
- num Affected
- 2
- num At Risk
- 6
- num Events
- 2
- term
- Constipation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 27.1
- stats
- group Id
- EG000
- num Affected
- 223
- num At Risk
- 406
- num Events
- 686
- group Id
- EG001
- num Affected
- 76
- num At Risk
- 388
- num Events
- 107
- group Id
- EG002
- num Affected
- 4
- num At Risk
- 21
- num Events
- 5
- group Id
- EG003
- num Affected
- 3
- num At Risk
- 6
- num Events
- 6
- term
- Diarrhoea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 27.1
- stats
- group Id
- EG000
- num Affected
- 43
- num At Risk
- 406
- num Events
- 51
- group Id
- EG001
- num Affected
- 12
- num At Risk
- 388
- num Events
- 16
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- term
- Dry mouth
Complete source fields
- description
- All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
- event Groups
- deaths Num Affected
- 317
- deaths Num At Risk
- 406
- description
- Participants with Endometrial cancer (EC) received lenvatinib 20 milligrams (mg) orally, once daily, plus pembrolizumab 200 mg intravenously, every 3 weeks in each 21-day cycle. Participants continued to receive treatment until disease progression, development of unacceptable toxicity, withdrawal of consent, completion of 35 treatments (approximately 2 years) with pembrolizumab, or sponsor termination of the study
- id
- EG000
- other Num Affected
- 404
- other Num At Risk
- 406
- serious Num Affected
- 237
- serious Num At Risk
- 406
- title
- First Course: Lenvatinib + Pembrolizumab
- deaths Num Affected
- 362
- deaths Num At Risk
- 388
- description
- Participants with EC received either doxorubicin 60 milligrams per square meter (mg/m\^2) intravenously, every 3 weeks, in each 21-day treatment cycle, or paclitaxel 80 mg/m\^2 intravenously, weekly (3 weeks on/1 week off), in each 28-day treatment cycle. Participants continued to receive treatment until a lifetime cumulative dose of 500 mg/m\^2 doxorubicin, a maximum dose of paclitaxel per standard of care, or until disease progression, development of unacceptable toxicity, withdrawal of consent, or sponsor termination of the study.
- id
- EG001
- other Num Affected
- 379
- other Num At Risk
- 388
- serious Num Affected
- 121
- serious Num At Risk
- 388
- title
- First Course: TPC Doxorubicin or Paclitaxel
- deaths Num Affected
- 8
- deaths Num At Risk
- 21
- description
- Eligible participants who completed the first course of up to 35 administrations of pembrolizumab (\~2 years) and lenvatinib (\~2years) or who had Stable disease (SD) or partial response (PR) or had attained complete response (CR), but experienced radiologic progression of disease (PD) initiated a second course of pembrolizumab and lenvatinib at investigators discretion at the same dose and schedule at lenvatinib 20 mg orally, once daily, plus pembrolizumab 200 mg intravenously, every 3 weeks in each 21-day cycle upto 17 cycles (upto \~1 year)
- id
- EG002
- other Num Affected
- 20
- other Num At Risk
- 21
- serious Num Affected
- 4
- serious Num At Risk
- 21
- title
- Second Course: Lenvatinib + Pembrolizumab
- deaths Num Affected
- 1
- deaths Num At Risk
- 6
- description
- Eligible participants who completed the first course of either doxorubicin 60 milligrams per square meter (mg/m\^2) intravenously, every 3 weeks, in each 21-day treatment cycle, or paclitaxel 80 mg/m\^2 intravenously, weekly (3 weeks on/1 week off), in each 28-day treatment cycle and eligible participants continued to receive treatment until a lifetime cumulative dose of 500 mg/m\^2 doxorubicin, a maximum dose of paclitaxel per standard of care or who had Stable disease (SD) or partial response (PR) or had attained complete response (CR), but experienced radiologic progression of disease (PD) initiated treatment with pembrolizumab and lenvatinib at investigators discretion at the same dose and schedule at lenvatinib 20 mg orally, once daily, plus pembrolizumab 200 mg intravenously, every 3 weeks in each 21-day cycle upto 17 cycles (upto \~1 year)
- id
- EG003
- other Num Affected
- 6
- other Num At Risk
- 6
- serious Num Affected
- 1
- serious Num At Risk
- 6
- title
- TPC Crossover
- frequency Threshold
- 5
- other Events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 27.1
- stats
- group Id
- EG000
- num Affected
- 115
- num At Risk
- 406
- num Events
- 171
- group Id
- EG001
- num Affected
- 181
- num At Risk
- 388
- num Events
- 240
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 21
- num Events
- 1
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 6
- num Events
- 3
- term
- Anaemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 27.1
- stats
- group Id
- EG000
- num Affected
- 28
- num At Risk
- 406
- num Events
- 72
- group Id
- EG001
- num Affected
- 50
- num At Risk
- 388
- num Events
- 89
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 21
- num Events
- 3
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- term
- Leukopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 27.1
- stats
- group Id
- EG000
- num Affected
- 26
- num At Risk
- 406
- num Events
- 61
- group Id
- EG001
- num Affected
- 30
- num At Risk
- 388
- num Events
- 45
- group Id
- EG002
- num Affected
- 2
- num At Risk
- 21
- num Events
- 5
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 6
- num Events
- 1
- term
- Lymphopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 27.1
- stats
- group Id
- EG000
- num Affected
- 38
- num At Risk
- 406
- num Events
- 106
- group Id
- EG001
- num Affected
- 125
- num At Risk
- 388
- num Events
- 213
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 21
- num Events
- 3
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- term
- Neutropenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 27.1
- stats
- group Id
- EG000
- num Affected
- 46
- num At Risk
- 406
- num Events
- 66
- group Id
- EG001
- num Affected
- 26
- num At Risk
- 388
- num Events
- 31
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- group Id
- EG003
- num Affected
- 2
- num At Risk
- 6
- num Events
- 3
- term
- Thrombocytopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Endocrine disorders
- source Vocabulary
- MedDRA 27.1
- stats
- group Id
- EG000
- num Affected
- 46
- num At Risk
- 406
- num Events
- 50
- group Id
- EG001
- num Affected
- 4
- num At Risk
- 388
- num Events
- 4
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 21
- num Events
- 1
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 6
- num Events
- 1
- term
- Hyperthyroidism
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Endocrine disorders
- source Vocabulary
- MedDRA 27.1
- stats
- group Id
- EG000
- num Affected
- 238
- num At Risk
- 406
- num Events
- 299
- group Id
- EG001
- num Affected
- 3
- num At Risk
- 388
- num Events
- 3
- group Id
- EG002
- num Affected
- 4
- num At Risk
- 21
- num Events
- 5
- group Id
- EG003
- num Affected
- 4
- num At Risk
- 6
- num Events
- 4
- term
- Hypothyroidism
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 27.1
- stats
- group Id
- EG000
- num Affected
- 96
- num At Risk
- 406
- num Events
- 141
- group Id
- EG001
- num Affected
- 52
- num At Risk
- 388
- num Events
- 58
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 6
- num Events
- 1
- term
- Abdominal pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 27.1
- stats
- group Id
- EG000
- num Affected
- 57
- num At Risk
- 406
- num Events
- 75
- group Id
- EG001
- num Affected
- 28
- num At Risk
- 388
- num Events
- 34
- group Id
- EG002
- num Affected
- 3
- num At Risk
- 21
- num Events
- 3
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 6
- num Events
- 1
- term
- Abdominal pain upper
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 27.1
- stats
- group Id
- EG000
- num Affected
- 116
- num At Risk
- 406
- num Events
- 142
- group Id
- EG001
- num Affected
- 95
- num At Risk
- 388
- num Events
- 119
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- group Id
- EG003
- num Affected
- 2
- num At Risk
- 6
- num Events
- 2
- term
- Constipation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 27.1
- stats
- group Id
- EG000
- num Affected
- 223
- num At Risk
- 406
- num Events
- 686
- group Id
- EG001
- num Affected
- 76
- num At Risk
- 388
- num Events
- 107
- group Id
- EG002
- num Affected
- 4
- num At Risk
- 21
- num Events
- 5
- group Id
- EG003
- num Affected
- 3
- num At Risk
- 6
- num Events
- 6
- term
- Diarrhoea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 27.1
- stats
- group Id
- EG000
- num Affected
- 43
- num At Risk
- 406
- num Events
- 51
- group Id
- EG001
- num Affected
- 12
- num At Risk
- 388
- num Events
- 16
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- term
- Dry mouth
- serious Events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 27.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 406
- num Events
- 1
- group Id
- EG001
- num Affected
- 9
- num At Risk
- 388
- num Events
- 9
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- term
- Anaemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 27.1
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 406
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 388
- num Events
- 1
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- term
- Febrile bone marrow aplasia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 27.1
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 406
- num Events
- 2
- group Id
- EG001
- num Affected
- 16
- num At Risk
- 388
- num Events
- 17
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- term
- Febrile neutropenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 27.1
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 406
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 388
- num Events
- 1
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- term
- Leukocytosis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 27.1
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 406
- num Events
- 0
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 388
- num Events
- 2
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- term
- Leukopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 27.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 406
- num Events
- 1
- group Id
- EG001
- num Affected
- 8
- num At Risk
- 388
- num Events
- 8
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- term
- Neutropenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 27.1
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 406
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 388
- num Events
- 1
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- term
- Neutrophilia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 27.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 406
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 388
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- term
- Pancytopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 27.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 406
- num Events
- 1
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 388
- num Events
- 1
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- term
- Thrombocytopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 27.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 406
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 388
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- term
- Thrombotic microangiopathy
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA 27.1
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 406
- num Events
- 2
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 388
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- term
- Acute coronary syndrome
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA 27.1
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 406
- num Events
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 388
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 6
- num Events
- 0
- term
- Acute myocardial infarction
- time Frame
- Up to approximately 79 months
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Preserved source evidence · Not medical advice
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