NCT03635567 · 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 66 months
- Other-event reporting threshold
- 5%
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
| Safety group | Serious events | Other events | Deaths |
|---|---|---|---|
| Pembrolizumab+Chemotherapy | 157 / 307 | 298 / 307 | 195 / 308 |
| Placebo+Chemotherapy | 132 / 309 | 299 / 309 | 241 / 309 |
| Pembrolizumab (Second Course) | 4 / 12 | 8 / 12 | 4 / 12 |
Serious adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 27.0
- stats
- group Id
- EG000
- num Affected
- 14
- num At Risk
- 307
- num Events
- 14
- group Id
- EG001
- num Affected
- 12
- num At Risk
- 309
- num Events
- 14
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 12
- num Events
- 0
- term
- Anaemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 27.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 307
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 309
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 12
- num Events
- 0
- term
- Bicytopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 27.0
- stats
- group Id
- EG000
- num Affected
- 21
- num At Risk
- 307
- num Events
- 25
- group Id
- EG001
- num Affected
- 13
- num At Risk
- 309
- num Events
- 14
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 12
- num Events
- 0
- term
- Febrile neutropenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 27.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 307
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 309
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 12
- num Events
- 0
- term
- Leukopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 27.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 307
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 309
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 12
- num Events
- 0
- term
- Lymphadenitis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 27.0
- stats
- group Id
- EG000
- num Affected
- 4
- num At Risk
- 307
- num Events
- 5
- group Id
- EG001
- num Affected
- 3
- num At Risk
- 309
- num Events
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 12
- num Events
- 0
- term
- Neutropenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 27.0
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 307
- num Events
- 2
- group Id
- EG001
- num Affected
- 3
- num At Risk
- 309
- num Events
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 12
- num Events
- 0
- term
- Pancytopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 27.0
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 307
- num Events
- 3
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 309
- num Events
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 12
- num Events
- 0
- term
- Thrombocytopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA 27.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 307
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 309
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 12
- num Events
- 0
- term
- Acute myocardial infarction
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA 27.0
- stats
- group Id
- EG000
- num Affected
- 4
- num At Risk
- 307
- num Events
- 4
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 309
- num Events
- 1
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 12
- num Events
- 0
- term
- Atrial fibrillation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA 27.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 307
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 309
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 12
- num Events
- 0
- term
- Bundle branch block
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA 27.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 307
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 309
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 12
- num Events
- 0
- term
- Cardiac arrest
Other reported adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 27.0
- stats
- group Id
- EG000
- num Affected
- 182
- num At Risk
- 307
- num Events
- 264
- group Id
- EG001
- num Affected
- 159
- num At Risk
- 309
- num Events
- 247
- group Id
- EG002
- num Affected
- 2
- num At Risk
- 12
- num Events
- 2
- term
- Anaemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 27.0
- stats
- group Id
- EG000
- num Affected
- 40
- num At Risk
- 307
- num Events
- 71
- group Id
- EG001
- num Affected
- 33
- num At Risk
- 309
- num Events
- 55
- group Id
- EG002
- num Affected
- 2
- num At Risk
- 12
- num Events
- 2
- term
- Leukopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 27.0
- stats
- group Id
- EG000
- num Affected
- 15
- num At Risk
- 307
- num Events
- 29
- group Id
- EG001
- num Affected
- 7
- num At Risk
- 309
- num Events
- 7
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 12
- num Events
- 1
- term
- Lymphopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 27.0
- stats
- group Id
- EG000
- num Affected
- 71
- num At Risk
- 307
- num Events
- 142
- group Id
- EG001
- num Affected
- 58
- num At Risk
- 309
- num Events
- 115
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 12
- num Events
- 0
- term
- Neutropenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 27.0
- stats
- group Id
- EG000
- num Affected
- 60
- num At Risk
- 307
- num Events
- 90
- group Id
- EG001
- num Affected
- 60
- num At Risk
- 309
- num Events
- 101
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 12
- num Events
- 0
- term
- Thrombocytopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Ear and labyrinth disorders
- source Vocabulary
- MedDRA 27.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 307
- num Events
- 0
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 309
- num Events
- 2
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 12
- num Events
- 1
- term
- Ear discomfort
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Endocrine disorders
- source Vocabulary
- MedDRA 27.0
- stats
- group Id
- EG000
- num Affected
- 24
- num At Risk
- 307
- num Events
- 26
- group Id
- EG001
- num Affected
- 9
- num At Risk
- 309
- num Events
- 10
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 12
- num Events
- 0
- term
- Hyperthyroidism
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Endocrine disorders
- source Vocabulary
- MedDRA 27.0
- stats
- group Id
- EG000
- num Affected
- 59
- num At Risk
- 307
- num Events
- 65
- group Id
- EG001
- num Affected
- 31
- num At Risk
- 309
- num Events
- 33
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 12
- num Events
- 0
- term
- Hypothyroidism
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 27.0
- stats
- group Id
- EG000
- num Affected
- 50
- num At Risk
- 307
- num Events
- 66
- group Id
- EG001
- num Affected
- 52
- num At Risk
- 309
- num Events
- 78
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 12
- num Events
- 0
- term
- Abdominal pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 27.0
- stats
- group Id
- EG000
- num Affected
- 16
- num At Risk
- 307
- num Events
- 18
- group Id
- EG001
- num Affected
- 12
- num At Risk
- 309
- num Events
- 13
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 12
- num Events
- 0
- term
- Abdominal pain lower
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 27.0
- stats
- group Id
- EG000
- num Affected
- 30
- num At Risk
- 307
- num Events
- 43
- group Id
- EG001
- num Affected
- 30
- num At Risk
- 309
- num Events
- 41
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 12
- num Events
- 0
- term
- Abdominal pain upper
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 27.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 307
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 309
- num Events
- 0
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 12
- num Events
- 1
- term
- Cheilitis
Complete source fields
- description
- Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
- event Groups
- deaths Num Affected
- 195
- deaths Num At Risk
- 308
- description
- On Day 1 of each 21-day cycle, participants received an intravenous (IV) infusion of pembrolizumab 200 mg for up to 35 cycles (up to approximately 2 years) PLUS Investigator choice of chemotherapy for up to 6 cycles (paclitaxel 175 mg/m\^2 PLUS cisplatin 50 mg/m\^2 WITH or WITHOUT bevacizumab 15 mg/kg per local label OR paclitaxel 175 mg/m\^2 PLUS carboplatin Area Under the Curve (AUC) 5 for up to 6 cycles, WITH or WITHOUT bevacizumab 15 mg/kg per local label). All treatments were administered until disease progression or toxicity. Eligible participants who stopped the initial course of pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.
- id
- EG000
- other Num Affected
- 298
- other Num At Risk
- 307
- serious Num Affected
- 157
- serious Num At Risk
- 307
- title
- Pembrolizumab+Chemotherapy
- deaths Num Affected
- 241
- deaths Num At Risk
- 309
- description
- On Day 1 of each 21-day cycle, participants received an IV infusion of placebo (Normal Saline or Dextrose solution) for up to 35 cycles (up to approximately 2 years) PLUS Investigator choice of chemotherapy for up to 6 cycles (paclitaxel 175 mg/m\^2 PLUS cisplatin 50 mg/m\^2 WITH or WITHOUT bevacizumab 15 mg/kg per local label OR paclitaxel 175 mg/m\^2 PLUS carboplatin AUC 5 for up to 6 cycles, WITH or WITHOUT bevacizumab 15 mg/kg per local label). All treatments were administered until disease progression or toxicity.
- id
- EG001
- other Num Affected
- 299
- other Num At Risk
- 309
- serious Num Affected
- 132
- serious Num At Risk
- 309
- title
- Placebo+Chemotherapy
- deaths Num Affected
- 4
- deaths Num At Risk
- 12
- description
- Eligible participants received up to 17 additional administrations (up to approximately 1 year) of pembrolizumab 200 mg IV on Day 1 of each 21-day cycle.
- id
- EG002
- other Num Affected
- 8
- other Num At Risk
- 12
- serious Num Affected
- 4
- serious Num At Risk
- 12
- title
- Pembrolizumab (Second Course)
- frequency Threshold
- 5
- other Events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 27.0
- stats
- group Id
- EG000
- num Affected
- 182
- num At Risk
- 307
- num Events
- 264
- group Id
- EG001
- num Affected
- 159
- num At Risk
- 309
- num Events
- 247
- group Id
- EG002
- num Affected
- 2
- num At Risk
- 12
- num Events
- 2
- term
- Anaemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 27.0
- stats
- group Id
- EG000
- num Affected
- 40
- num At Risk
- 307
- num Events
- 71
- group Id
- EG001
- num Affected
- 33
- num At Risk
- 309
- num Events
- 55
- group Id
- EG002
- num Affected
- 2
- num At Risk
- 12
- num Events
- 2
- term
- Leukopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 27.0
- stats
- group Id
- EG000
- num Affected
- 15
- num At Risk
- 307
- num Events
- 29
- group Id
- EG001
- num Affected
- 7
- num At Risk
- 309
- num Events
- 7
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 12
- num Events
- 1
- term
- Lymphopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 27.0
- stats
- group Id
- EG000
- num Affected
- 71
- num At Risk
- 307
- num Events
- 142
- group Id
- EG001
- num Affected
- 58
- num At Risk
- 309
- num Events
- 115
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 12
- num Events
- 0
- term
- Neutropenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 27.0
- stats
- group Id
- EG000
- num Affected
- 60
- num At Risk
- 307
- num Events
- 90
- group Id
- EG001
- num Affected
- 60
- num At Risk
- 309
- num Events
- 101
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 12
- num Events
- 0
- term
- Thrombocytopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Ear and labyrinth disorders
- source Vocabulary
- MedDRA 27.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 307
- num Events
- 0
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 309
- num Events
- 2
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 12
- num Events
- 1
- term
- Ear discomfort
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Endocrine disorders
- source Vocabulary
- MedDRA 27.0
- stats
- group Id
- EG000
- num Affected
- 24
- num At Risk
- 307
- num Events
- 26
- group Id
- EG001
- num Affected
- 9
- num At Risk
- 309
- num Events
- 10
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 12
- num Events
- 0
- term
- Hyperthyroidism
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Endocrine disorders
- source Vocabulary
- MedDRA 27.0
- stats
- group Id
- EG000
- num Affected
- 59
- num At Risk
- 307
- num Events
- 65
- group Id
- EG001
- num Affected
- 31
- num At Risk
- 309
- num Events
- 33
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 12
- num Events
- 0
- term
- Hypothyroidism
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 27.0
- stats
- group Id
- EG000
- num Affected
- 50
- num At Risk
- 307
- num Events
- 66
- group Id
- EG001
- num Affected
- 52
- num At Risk
- 309
- num Events
- 78
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 12
- num Events
- 0
- term
- Abdominal pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 27.0
- stats
- group Id
- EG000
- num Affected
- 16
- num At Risk
- 307
- num Events
- 18
- group Id
- EG001
- num Affected
- 12
- num At Risk
- 309
- num Events
- 13
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 12
- num Events
- 0
- term
- Abdominal pain lower
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 27.0
- stats
- group Id
- EG000
- num Affected
- 30
- num At Risk
- 307
- num Events
- 43
- group Id
- EG001
- num Affected
- 30
- num At Risk
- 309
- num Events
- 41
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 12
- num Events
- 0
- term
- Abdominal pain upper
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 27.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 307
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 309
- num Events
- 0
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 12
- num Events
- 1
- term
- Cheilitis
- serious Events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 27.0
- stats
- group Id
- EG000
- num Affected
- 14
- num At Risk
- 307
- num Events
- 14
- group Id
- EG001
- num Affected
- 12
- num At Risk
- 309
- num Events
- 14
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 12
- num Events
- 0
- term
- Anaemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 27.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 307
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 309
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 12
- num Events
- 0
- term
- Bicytopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 27.0
- stats
- group Id
- EG000
- num Affected
- 21
- num At Risk
- 307
- num Events
- 25
- group Id
- EG001
- num Affected
- 13
- num At Risk
- 309
- num Events
- 14
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 12
- num Events
- 0
- term
- Febrile neutropenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 27.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 307
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 309
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 12
- num Events
- 0
- term
- Leukopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 27.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 307
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 309
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 12
- num Events
- 0
- term
- Lymphadenitis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 27.0
- stats
- group Id
- EG000
- num Affected
- 4
- num At Risk
- 307
- num Events
- 5
- group Id
- EG001
- num Affected
- 3
- num At Risk
- 309
- num Events
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 12
- num Events
- 0
- term
- Neutropenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 27.0
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 307
- num Events
- 2
- group Id
- EG001
- num Affected
- 3
- num At Risk
- 309
- num Events
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 12
- num Events
- 0
- term
- Pancytopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 27.0
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 307
- num Events
- 3
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 309
- num Events
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 12
- num Events
- 0
- term
- Thrombocytopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA 27.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 307
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 309
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 12
- num Events
- 0
- term
- Acute myocardial infarction
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA 27.0
- stats
- group Id
- EG000
- num Affected
- 4
- num At Risk
- 307
- num Events
- 4
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 309
- num Events
- 1
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 12
- num Events
- 0
- term
- Atrial fibrillation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA 27.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 307
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 309
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 12
- num Events
- 0
- term
- Bundle branch block
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA 27.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 307
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 309
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 12
- num Events
- 0
- term
- Cardiac arrest
- time Frame
- Up to approximately 66 months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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