NCT00516321 · 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
- Adverse events (AEs) are reported for the Double-blind (DB) on-treatment + 30 days period (up to Study Week 72).
- Other-event reporting threshold
- 5%
In the study, AEs were collected during the Open-Label (OL) Pre-Antiviral Treatment Phase and the Double-Blind (DB) Phase, which included antiviral therapy and a 6-month post-therapy follow-up. Data for SAEs and AEs are presented for the Safety Population, comprised of all randomized participants who received the study drug.
| Safety group | Serious events | Other events | Deaths |
|---|---|---|---|
| Eltrombopag: OL Phase | 8 / 715 | 49 / 715 | Not reported / Not reported |
| Placebo+Antiviral Therapy: DB Phase | 35 / 232 | 219 / 232 | Not reported / Not reported |
| Eltrombopag+Antiviral Therapy: DB Phase | 89 / 449 | 424 / 449 | Not reported / Not reported |
Serious adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 715
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 232
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 449
- term
- Gastric Hemorrhage
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 715
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 232
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 449
- term
- Hemorrhoids
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 715
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 232
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 449
- term
- Large Intestine Perforation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 715
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 232
- group Id
- EG002
- num Affected
- 7
- num At Risk
- 449
- term
- Oesophageal Varices Hemorrhage
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Neoplasms benign, malignant and unspecified (incl cysts and polyps)
- source Vocabulary
- MedDRA
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 715
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 232
- group Id
- EG002
- num Affected
- 6
- num At Risk
- 449
- term
- Hepatic Neoplasm Malignant
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- MedDRA
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 715
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 232
- group Id
- EG002
- num Affected
- 3
- num At Risk
- 449
- term
- Pyrexia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- MedDRA
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 715
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 232
- group Id
- EG002
- num Affected
- 4
- num At Risk
- 449
- term
- Pneumonia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Vascular disorders
- source Vocabulary
- MedDRA
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 715
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 232
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 449
- term
- Hypertensive Crisis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 715
- group Id
- EG001
- num Affected
- 3
- num At Risk
- 232
- group Id
- EG002
- num Affected
- 4
- num At Risk
- 449
- term
- Ascites
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 715
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 232
- group Id
- EG002
- num Affected
- 4
- num At Risk
- 449
- term
- Upper Gastrointestinal Hemorrhage
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 715
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 232
- group Id
- EG002
- num Affected
- 2
- num At Risk
- 449
- term
- Colitis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 715
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 232
- group Id
- EG002
- num Affected
- 2
- num At Risk
- 449
- term
- Diarrhea
Other reported adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Nervous system disorders
- source Vocabulary
- MedDRA
- stats
- group Id
- EG000
- num Affected
- 49
- num At Risk
- 715
- group Id
- EG001
- num Affected
- 47
- num At Risk
- 232
- group Id
- EG002
- num Affected
- 107
- num At Risk
- 449
- term
- Headache
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 715
- group Id
- EG001
- num Affected
- 95
- num At Risk
- 232
- group Id
- EG002
- num Affected
- 170
- num At Risk
- 449
- term
- Neutropenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 715
- group Id
- EG001
- num Affected
- 78
- num At Risk
- 232
- group Id
- EG002
- num Affected
- 183
- num At Risk
- 449
- term
- Anemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 715
- group Id
- EG001
- num Affected
- 85
- num At Risk
- 232
- group Id
- EG002
- num Affected
- 69
- num At Risk
- 449
- term
- Thrombocytopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 715
- group Id
- EG001
- num Affected
- 39
- num At Risk
- 232
- group Id
- EG002
- num Affected
- 70
- num At Risk
- 449
- term
- Leukopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- MedDRA
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 715
- group Id
- EG001
- num Affected
- 60
- num At Risk
- 232
- group Id
- EG002
- num Affected
- 139
- num At Risk
- 449
- term
- Fatigue
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- MedDRA
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 715
- group Id
- EG001
- num Affected
- 53
- num At Risk
- 232
- group Id
- EG002
- num Affected
- 139
- num At Risk
- 449
- term
- Pyrexia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- MedDRA
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 715
- group Id
- EG001
- num Affected
- 40
- num At Risk
- 232
- group Id
- EG002
- num Affected
- 70
- num At Risk
- 449
- term
- Influenza Like Illness
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- MedDRA
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 715
- group Id
- EG001
- num Affected
- 34
- num At Risk
- 232
- group Id
- EG002
- num Affected
- 66
- num At Risk
- 449
- term
- Asthenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- MedDRA
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 715
- group Id
- EG001
- num Affected
- 20
- num At Risk
- 232
- group Id
- EG002
- num Affected
- 56
- num At Risk
- 449
- term
- Edema Peripheral
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- MedDRA
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 715
- group Id
- EG001
- num Affected
- 12
- num At Risk
- 232
- group Id
- EG002
- num Affected
- 58
- num At Risk
- 449
- term
- Chills
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- MedDRA
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 715
- group Id
- EG001
- num Affected
- 17
- num At Risk
- 232
- group Id
- EG002
- num Affected
- 46
- num At Risk
- 449
- term
- Irritability
Complete source fields
- description
- In the study, AEs were collected during the Open-Label (OL) Pre-Antiviral Treatment Phase and the Double-Blind (DB) Phase, which included antiviral therapy and a 6-month post-therapy follow-up. Data for SAEs and AEs are presented for the Safety Population, comprised of all randomized participants who received the study drug.
- event Groups
- description
- Participants with a platelet count of \<75 giga (10\^9) cells per liter (Gi/L) initially received eltrombopag 25 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was \<90 Gi/L, participants underwent dose escalation to 50 mg QD for 2 weeks. If platelet counts still remained \<90 Gi/L, further dose escalations to 75 mg QD (up to 2 weeks) and 100 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts \>=90 Gi/L during the OL Phase (maximum of up to 9 weeks) were eligible to enter the Double-blind (DB) Antiviral Treatment Phase, whereas those who failed to reach platelet counts \>=90 Gi/L were discontinued from eltrombopag and had to attend the post-treatment follow-up visits.
- id
- EG000
- other Num Affected
- 49
- other Num At Risk
- 715
- serious Num Affected
- 8
- serious Num At Risk
- 715
- title
- Eltrombopag: OL Phase
- description
- Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
- id
- EG001
- other Num Affected
- 219
- other Num At Risk
- 232
- serious Num Affected
- 35
- serious Num At Risk
- 232
- title
- Placebo+Antiviral Therapy: DB Phase
- description
- Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to \>=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
- id
- EG002
- other Num Affected
- 424
- other Num At Risk
- 449
- serious Num Affected
- 89
- serious Num At Risk
- 449
- title
- Eltrombopag+Antiviral Therapy: DB Phase
- frequency Threshold
- 5
- other Events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Nervous system disorders
- source Vocabulary
- MedDRA
- stats
- group Id
- EG000
- num Affected
- 49
- num At Risk
- 715
- group Id
- EG001
- num Affected
- 47
- num At Risk
- 232
- group Id
- EG002
- num Affected
- 107
- num At Risk
- 449
- term
- Headache
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 715
- group Id
- EG001
- num Affected
- 95
- num At Risk
- 232
- group Id
- EG002
- num Affected
- 170
- num At Risk
- 449
- term
- Neutropenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 715
- group Id
- EG001
- num Affected
- 78
- num At Risk
- 232
- group Id
- EG002
- num Affected
- 183
- num At Risk
- 449
- term
- Anemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 715
- group Id
- EG001
- num Affected
- 85
- num At Risk
- 232
- group Id
- EG002
- num Affected
- 69
- num At Risk
- 449
- term
- Thrombocytopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 715
- group Id
- EG001
- num Affected
- 39
- num At Risk
- 232
- group Id
- EG002
- num Affected
- 70
- num At Risk
- 449
- term
- Leukopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- MedDRA
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 715
- group Id
- EG001
- num Affected
- 60
- num At Risk
- 232
- group Id
- EG002
- num Affected
- 139
- num At Risk
- 449
- term
- Fatigue
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- MedDRA
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 715
- group Id
- EG001
- num Affected
- 53
- num At Risk
- 232
- group Id
- EG002
- num Affected
- 139
- num At Risk
- 449
- term
- Pyrexia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- MedDRA
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 715
- group Id
- EG001
- num Affected
- 40
- num At Risk
- 232
- group Id
- EG002
- num Affected
- 70
- num At Risk
- 449
- term
- Influenza Like Illness
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- MedDRA
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 715
- group Id
- EG001
- num Affected
- 34
- num At Risk
- 232
- group Id
- EG002
- num Affected
- 66
- num At Risk
- 449
- term
- Asthenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- MedDRA
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 715
- group Id
- EG001
- num Affected
- 20
- num At Risk
- 232
- group Id
- EG002
- num Affected
- 56
- num At Risk
- 449
- term
- Edema Peripheral
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- MedDRA
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 715
- group Id
- EG001
- num Affected
- 12
- num At Risk
- 232
- group Id
- EG002
- num Affected
- 58
- num At Risk
- 449
- term
- Chills
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- MedDRA
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 715
- group Id
- EG001
- num Affected
- 17
- num At Risk
- 232
- group Id
- EG002
- num Affected
- 46
- num At Risk
- 449
- term
- Irritability
- serious Events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 715
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 232
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 449
- term
- Gastric Hemorrhage
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 715
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 232
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 449
- term
- Hemorrhoids
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 715
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 232
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 449
- term
- Large Intestine Perforation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 715
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 232
- group Id
- EG002
- num Affected
- 7
- num At Risk
- 449
- term
- Oesophageal Varices Hemorrhage
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Neoplasms benign, malignant and unspecified (incl cysts and polyps)
- source Vocabulary
- MedDRA
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 715
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 232
- group Id
- EG002
- num Affected
- 6
- num At Risk
- 449
- term
- Hepatic Neoplasm Malignant
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- MedDRA
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 715
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 232
- group Id
- EG002
- num Affected
- 3
- num At Risk
- 449
- term
- Pyrexia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- MedDRA
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 715
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 232
- group Id
- EG002
- num Affected
- 4
- num At Risk
- 449
- term
- Pneumonia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Vascular disorders
- source Vocabulary
- MedDRA
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 715
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 232
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 449
- term
- Hypertensive Crisis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 715
- group Id
- EG001
- num Affected
- 3
- num At Risk
- 232
- group Id
- EG002
- num Affected
- 4
- num At Risk
- 449
- term
- Ascites
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 715
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 232
- group Id
- EG002
- num Affected
- 4
- num At Risk
- 449
- term
- Upper Gastrointestinal Hemorrhage
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 715
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 232
- group Id
- EG002
- num Affected
- 2
- num At Risk
- 449
- term
- Colitis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 715
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 232
- group Id
- EG002
- num Affected
- 2
- num At Risk
- 449
- term
- Diarrhea
- time Frame
- Adverse events (AEs) are reported for the Double-blind (DB) on-treatment + 30 days period (up to Study Week 72).
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