NCT04847050 · 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
- From study product administration on Day 1 through 28 days after the last vaccination (through resolution); a median of 19.5 months.
- Other-event reporting threshold
- 0%
| Safety group | Serious events | Other events | Deaths |
|---|---|---|---|
| Hematologic Low Immunosuppression - Initial Phase | 0 / 2 | 2 / 2 | 0 / 2 |
| Hematologic Intermediate Immunosuppression - Initial Phase | 0 / 3 | 1 / 3 | 0 / 3 |
| Hematologic High Immunosuppression - Initial Phase | 2 / 7 | 6 / 7 | 0 / 7 |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | 1 / 3 | 2 / 3 | 0 / 3 |
| Other Hematologic Malignancy - Booster Phase | 0 / 4 | 3 / 4 | 0 / 4 |
Serious adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Immune system disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG002
- num Affected
- 2
- num At Risk
- 7
- num Events
- 2
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 4
- num Events
- 0
- term
- Immune system disorders - Other, Graft versus host disease (GVHD)
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Respiratory, thoracic and mediastinal disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 7
- num Events
- 0
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 3
- num Events
- 1
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 4
- num Events
- 0
- term
- Pneumothorax
Other reported adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 7
- num Events
- 1
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 4
- num Events
- 0
- term
- Anal hemorrhage
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Metabolism and nutrition disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 7
- num Events
- 1
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 4
- num Events
- 0
- term
- Anorexia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Musculoskeletal and connective tissue disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 2
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 7
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 4
- num Events
- 1
- term
- Arthralgia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Eye disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 7
- num Events
- 1
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 4
- num Events
- 0
- term
- Blurred vision
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG002
- num Affected
- 2
- num At Risk
- 7
- num Events
- 2
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 4
- num Events
- 0
- term
- Conjunctivitis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 7
- num Events
- 1
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 4
- num Events
- 0
- term
- Constipation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Respiratory, thoracic and mediastinal disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 2
- num Events
- 2
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 7
- num Events
- 1
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 3
- num Events
- 1
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 4
- num Events
- 0
- term
- Cough
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 7
- num Events
- 1
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 4
- num Events
- 0
- term
- Creatinine increased
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 7
- num Events
- 0
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 3
- num Events
- 1
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 4
- num Events
- 0
- term
- Dental caries
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 7
- num Events
- 1
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 4
- num Events
- 0
- term
- Dry mouth
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Nervous system disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 7
- num Events
- 1
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 4
- num Events
- 0
- term
- Dysgeusia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Respiratory, thoracic and mediastinal disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 2
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 7
- num Events
- 0
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 3
- num Events
- 1
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 4
- num Events
- 0
- term
- Dyspnea
Complete source fields
- event Groups
- deaths Num Affected
- 0
- deaths Num At Risk
- 2
- description
- 100 mcg (0.5 mL) messenger ribonucleic acid (mRNA)-1273 injection, intramuscular (IM) on days 1 and 29; with option for subsequent booster dose, 100 mcg (0.5 mL) mRNA-1273 injection (IM) no less than 4 weeks after day 29.
- id
- EG000
- other Num Affected
- 2
- other Num At Risk
- 2
- serious Num Affected
- 0
- serious Num At Risk
- 2
- title
- Hematologic Low Immunosuppression - Initial Phase
- deaths Num Affected
- 0
- deaths Num At Risk
- 3
- description
- 100 mcg (0.5 mL) messenger ribonucleic acid (mRNA)-1273 injection, intramuscular (IM) on days 1 and 29; with option for subsequent booster dose, 100 mcg (0.5 mL) mRNA-1273 injection (IM) no less than 4 weeks after day 29.
- id
- EG001
- other Num Affected
- 1
- other Num At Risk
- 3
- serious Num Affected
- 0
- serious Num At Risk
- 3
- title
- Hematologic Intermediate Immunosuppression - Initial Phase
- deaths Num Affected
- 0
- deaths Num At Risk
- 7
- description
- 100 mcg (0.5 mL) messenger ribonucleic acid (mRNA)-1273 injection, intramuscular (IM) on days 1 and 29; with option for subsequent booster dose, 100 mcg (0.5 mL) mRNA-1273 injection (IM) no less than 4 weeks after day 29
- id
- EG002
- other Num Affected
- 6
- other Num At Risk
- 7
- serious Num Affected
- 2
- serious Num At Risk
- 7
- title
- Hematologic High Immunosuppression - Initial Phase
- deaths Num Affected
- 0
- deaths Num At Risk
- 3
- description
- 100 mcg (0.5 mL) messenger ribonucleic acid (mRNA)-1273 injection, intramuscular (IM) on days 1 and 29; with option for subsequent booster dose, 100 mcg (0.5 mL) mRNA-1273 injection (IM) no less than 4 weeks after day 29.
- id
- EG003
- other Num Affected
- 2
- other Num At Risk
- 3
- serious Num Affected
- 1
- serious Num At Risk
- 3
- title
- Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase
- deaths Num Affected
- 0
- deaths Num At Risk
- 4
- description
- 100 mcg (0.5 mL) messenger ribonucleic acid (mRNA)-1273 injection, intramuscular (IM) on day 1.
- id
- EG004
- other Num Affected
- 3
- other Num At Risk
- 4
- serious Num Affected
- 0
- serious Num At Risk
- 4
- title
- Other Hematologic Malignancy - Booster Phase
- frequency Threshold
- 0
- other Events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 7
- num Events
- 1
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 4
- num Events
- 0
- term
- Anal hemorrhage
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Metabolism and nutrition disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 7
- num Events
- 1
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 4
- num Events
- 0
- term
- Anorexia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Musculoskeletal and connective tissue disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 2
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 7
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 4
- num Events
- 1
- term
- Arthralgia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Eye disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 7
- num Events
- 1
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 4
- num Events
- 0
- term
- Blurred vision
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG002
- num Affected
- 2
- num At Risk
- 7
- num Events
- 2
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 4
- num Events
- 0
- term
- Conjunctivitis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 7
- num Events
- 1
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 4
- num Events
- 0
- term
- Constipation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Respiratory, thoracic and mediastinal disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 2
- num Events
- 2
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 7
- num Events
- 1
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 3
- num Events
- 1
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 4
- num Events
- 0
- term
- Cough
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 7
- num Events
- 1
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 4
- num Events
- 0
- term
- Creatinine increased
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 7
- num Events
- 0
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 3
- num Events
- 1
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 4
- num Events
- 0
- term
- Dental caries
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 7
- num Events
- 1
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 4
- num Events
- 0
- term
- Dry mouth
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Nervous system disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 7
- num Events
- 1
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 4
- num Events
- 0
- term
- Dysgeusia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Respiratory, thoracic and mediastinal disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 2
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 7
- num Events
- 0
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 3
- num Events
- 1
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 4
- num Events
- 0
- term
- Dyspnea
- serious Events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Immune system disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG002
- num Affected
- 2
- num At Risk
- 7
- num Events
- 2
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 4
- num Events
- 0
- term
- Immune system disorders - Other, Graft versus host disease (GVHD)
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Respiratory, thoracic and mediastinal disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 7
- num Events
- 0
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 3
- num Events
- 1
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 4
- num Events
- 0
- term
- Pneumothorax
- time Frame
- From study product administration on Day 1 through 28 days after the last vaccination (through resolution); a median of 19.5 months.
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
Triangle