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NCT04306900 · ADVERSE EVENTS

Adverse events

TTX-030 in Combination With Immunotherapy and/or Chemotherapy in Subjects With Advanced Cancers · Source last updated 2025-07-29

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 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Other-event reporting threshold
5%

Safety population = all participants who received at least one dose or any partial dose of TTX-030.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Cohort 1 - Safety Lead-in (TTX-030 + Budigalimab + mFOLFOX6)

Participants in Cohort 1 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15, plus budigalimab at a dose of 500 mg (Q4W) on Day 1 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.

4 / 88 / 82 / 8
Cohort 3B - Gastric (TTX-030 + Budigalimab + mFOLFOX6)

Participants in Cohort 3B were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15, plus budigalimab at a dose of 500 mg (Q4W) on Day 1 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.

27 / 4443 / 4413 / 44
Cohort 12 - Gastric (Budigalimab + mFOLFOX6)

Participants in Cohort 12 were administered IV budigalimab at a dose of 500 mg (Q4W) on Day 1 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.

16 / 2525 / 257 / 25
Cohort 3A - Gastric (TTX-030 + mFOLFOX6)

Participants in Cohort 3A were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.

2 / 66 / 62 / 6
Cohort 2 - mCRPC (TTX-030 + Budigalimab + Docetaxel)

Participants in Safety Lead-in Cohort 2 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab 375 mg Q3W plus docetaxel at a dose of 75 mg/m2 Q3W on Day 1 of each 21-day treatment cycle.

4 / 77 / 70 / 7
Cohort 9 - Pancreatic (TTX-030 + Budigalimab + Gemcitabine + Nab-Paclitaxel)

Participants in Cohort 9 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15 plus budigalimab at a dose of 500 mg (Q4W) on Day 1 plus gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.

16 / 2828 / 2811 / 28
Cohort 11 - Pancreatic (TTX-030 + Gemcitabine + Nab-Paclitaxel)

Participants in Cohort 11 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15 plus gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.

8 / 1717 / 178 / 17
Cohort 4 - CRC (TTX-030 + Budigalimab)

Participants in Cohort 4 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab at a dose of 375 mg Q3W on Day 1 of each 21-day treatment cycle.

4 / 1414 / 147 / 14
Cohort 6 - HNSCC (TTX-030 + Budigalimab)

Participants in Cohort 6 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab at a dose of 375 mg Q3W on Day 1 of each 21-day treatment cycle.

2 / 51 / 52 / 5
Cohort 8 - GEC (TTX-030 + Budigalimab)

Participants in Cohort 8 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab at a dose of 375 mg Q3W on Day 1 of each 21-day treatment cycle.

10 / 2323 / 2310 / 23
Cohort 10 - UCC (TTX-030 + Pembrolizumab)

Participants in Cohort 10 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus pembrolizumab at a dose of 200 mg Q3W on Day 1 of each 21-day treatment cycle.

3 / 88 / 82 / 8

Group identifiers: EG000: Cohort 1 - Safety Lead-in (TTX-030 + Budigalimab + mFOLFOX6) · EG001: Cohort 3B - Gastric (TTX-030 + Budigalimab + mFOLFOX6) · EG002: Cohort 12 - Gastric (Budigalimab + mFOLFOX6) · EG003: Cohort 3A - Gastric (TTX-030 + mFOLFOX6) · EG004: Cohort 2 - mCRPC (TTX-030 + Budigalimab + Docetaxel) · EG005: Cohort 9 - Pancreatic (TTX-030 + Budigalimab + Gemcitabine + Nab-Paclitaxel) · EG006: Cohort 11 - Pancreatic (TTX-030 + Gemcitabine + Nab-Paclitaxel) · EG007: Cohort 4 - CRC (TTX-030 + Budigalimab) · EG008: Cohort 6 - HNSCC (TTX-030 + Budigalimab) · EG009: Cohort 8 - GEC (TTX-030 + Budigalimab) · EG010: Cohort 10 - UCC (TTX-030 + Pembrolizumab)

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      44
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      28
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      17
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      14
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      23
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      44
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      28
      num Events
      1
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      17
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      14
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      23
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Anemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      44
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      28
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      17
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      14
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      23
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Blood loss anemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      44
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      28
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      17
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      14
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      23
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      44
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      28
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      17
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      14
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      23
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Atrial fibrillation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      44
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      28
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      17
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      14
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      23
      num Events
      1
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Hypophysitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      44
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      25
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      28
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      17
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      14
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      23
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Gastric haemorrhage
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      44
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      25
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      28
      num Events
      1
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      17
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      14
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      23
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Gastrointestinal haemorrhage
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      44
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      25
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      28
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      17
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      14
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      23
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Obstruction gastric
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      44
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      28
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      17
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      14
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      23
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Small intestinal obstruction
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      44
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      28
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      17
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      14
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      23
      num Events
      1
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Abdominal pain upper
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      44
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      28
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      17
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      14
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      23
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Anal fistula

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      44
      num Events
      11
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      25
      num Events
      1
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      6
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      5
      num At Risk
      28
      num Events
      5
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      17
      num Events
      3
    8. group Id
      EG007
      num Affected
      3
      num At Risk
      14
      num Events
      3
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      7
      num At Risk
      23
      num Events
      7
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      44
      num Events
      9
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      25
      num Events
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      7
      num At Risk
      28
      num Events
      7
    7. group Id
      EG006
      num Affected
      4
      num At Risk
      17
      num Events
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      14
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      23
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Alanine aminotransferase increased
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      1
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      44
      num Events
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      25
      num Events
      1
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      6
      num Events
      2
    5. group Id
      EG004
      num Affected
      5
      num At Risk
      7
      num Events
      5
    6. group Id
      EG005
      num Affected
      12
      num At Risk
      28
      num Events
      12
    7. group Id
      EG006
      num Affected
      6
      num At Risk
      17
      num Events
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      14
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      23
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Alopecia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      8
      num Events
      2
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      44
      num Events
      9
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      25
      num Events
      7
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      6
      num Events
      2
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      7
      num Events
      2
    6. group Id
      EG005
      num Affected
      15
      num At Risk
      28
      num Events
      15
    7. group Id
      EG006
      num Affected
      7
      num At Risk
      17
      num Events
      7
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      14
      num Events
      0
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      5
      num Events
      1
    10. group Id
      EG009
      num Affected
      4
      num At Risk
      23
      num Events
      4
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      8
      num Events
      1
    term
    Anemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      44
      num Events
      8
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      25
      num Events
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      9
      num At Risk
      28
      num Events
      9
    7. group Id
      EG006
      num Affected
      4
      num At Risk
      17
      num Events
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      14
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      23
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Aspartate aminotransferase increased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      44
      num Events
      18
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      25
      num Events
      5
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      6
      num Events
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      7
      num Events
      1
    6. group Id
      EG005
      num Affected
      6
      num At Risk
      28
      num Events
      6
    7. group Id
      EG006
      num Affected
      6
      num At Risk
      17
      num Events
      6
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      14
      num Events
      2
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      7
      num At Risk
      23
      num Events
      7
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      8
      num Events
      1
    term
    Constipation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      44
      num Events
      7
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      25
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      28
      num Events
      1
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      17
      num Events
      2
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      14
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      6
      num At Risk
      23
      num Events
      6
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      8
      num Events
      1
    term
    Cough
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      1
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      44
      num Events
      10
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      25
      num Events
      7
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
      num Events
      1
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      7
      num Events
      2
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      28
      num Events
      3
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      17
      num Events
      2
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      14
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      23
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    COVID-19
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      1
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      44
      num Events
      19
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      25
      num Events
      8
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      6
      num Events
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      10
      num At Risk
      28
      num Events
      10
    7. group Id
      EG006
      num Affected
      7
      num At Risk
      17
      num Events
      7
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      14
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      10
      num At Risk
      23
      num Events
      10
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Decreased appetite
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      1
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      44
      num Events
      19
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      25
      num Events
      6
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      6
      num Events
      2
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      7
      num Events
      2
    6. group Id
      EG005
      num Affected
      10
      num At Risk
      28
      num Events
      10
    7. group Id
      EG006
      num Affected
      5
      num At Risk
      17
      num Events
      5
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      14
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      23
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Diarrhea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      44
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
      num Events
      1
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      7
      num Events
      2
    6. group Id
      EG005
      num Affected
      8
      num At Risk
      28
      num Events
      8
    7. group Id
      EG006
      num Affected
      4
      num At Risk
      17
      num Events
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      14
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      6
      num At Risk
      23
      num Events
      6
    11. group Id
      EG010
      num Affected
      2
      num At Risk
      8
      num Events
      2
    term
    Edema peripheral
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      8
      num Events
      2
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      44
      num Events
      17
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      25
      num Events
      6
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      6
      num Events
      2
    5. group Id
      EG004
      num Affected
      7
      num At Risk
      7
      num Events
      7
    6. group Id
      EG005
      num Affected
      18
      num At Risk
      28
      num Events
      18
    7. group Id
      EG006
      num Affected
      11
      num At Risk
      17
      num Events
      11
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      14
      num Events
      2
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      11
      num At Risk
      23
      num Events
      11
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Fatigue
Complete source fields
description
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
event Groups
  1. deaths Num Affected
    2
    deaths Num At Risk
    8
    description
    Participants in Cohort 1 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15, plus budigalimab at a dose of 500 mg (Q4W) on Day 1 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
    id
    EG000
    other Num Affected
    8
    other Num At Risk
    8
    serious Num Affected
    4
    serious Num At Risk
    8
    title
    Cohort 1 - Safety Lead-in (TTX-030 + Budigalimab + mFOLFOX6)
  2. deaths Num Affected
    13
    deaths Num At Risk
    44
    description
    Participants in Cohort 3B were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15, plus budigalimab at a dose of 500 mg (Q4W) on Day 1 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
    id
    EG001
    other Num Affected
    43
    other Num At Risk
    44
    serious Num Affected
    27
    serious Num At Risk
    44
    title
    Cohort 3B - Gastric (TTX-030 + Budigalimab + mFOLFOX6)
  3. deaths Num Affected
    7
    deaths Num At Risk
    25
    description
    Participants in Cohort 12 were administered IV budigalimab at a dose of 500 mg (Q4W) on Day 1 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
    id
    EG002
    other Num Affected
    25
    other Num At Risk
    25
    serious Num Affected
    16
    serious Num At Risk
    25
    title
    Cohort 12 - Gastric (Budigalimab + mFOLFOX6)
  4. deaths Num Affected
    2
    deaths Num At Risk
    6
    description
    Participants in Cohort 3A were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
    id
    EG003
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    2
    serious Num At Risk
    6
    title
    Cohort 3A - Gastric (TTX-030 + mFOLFOX6)
  5. deaths Num Affected
    0
    deaths Num At Risk
    7
    description
    Participants in Safety Lead-in Cohort 2 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab 375 mg Q3W plus docetaxel at a dose of 75 mg/m2 Q3W on Day 1 of each 21-day treatment cycle.
    id
    EG004
    other Num Affected
    7
    other Num At Risk
    7
    serious Num Affected
    4
    serious Num At Risk
    7
    title
    Cohort 2 - mCRPC (TTX-030 + Budigalimab + Docetaxel)
  6. deaths Num Affected
    11
    deaths Num At Risk
    28
    description
    Participants in Cohort 9 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15 plus budigalimab at a dose of 500 mg (Q4W) on Day 1 plus gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.
    id
    EG005
    other Num Affected
    28
    other Num At Risk
    28
    serious Num Affected
    16
    serious Num At Risk
    28
    title
    Cohort 9 - Pancreatic (TTX-030 + Budigalimab + Gemcitabine + Nab-Paclitaxel)
  7. deaths Num Affected
    8
    deaths Num At Risk
    17
    description
    Participants in Cohort 11 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15 plus gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.
    id
    EG006
    other Num Affected
    17
    other Num At Risk
    17
    serious Num Affected
    8
    serious Num At Risk
    17
    title
    Cohort 11 - Pancreatic (TTX-030 + Gemcitabine + Nab-Paclitaxel)
  8. deaths Num Affected
    7
    deaths Num At Risk
    14
    description
    Participants in Cohort 4 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab at a dose of 375 mg Q3W on Day 1 of each 21-day treatment cycle.
    id
    EG007
    other Num Affected
    14
    other Num At Risk
    14
    serious Num Affected
    4
    serious Num At Risk
    14
    title
    Cohort 4 - CRC (TTX-030 + Budigalimab)
  9. deaths Num Affected
    2
    deaths Num At Risk
    5
    description
    Participants in Cohort 6 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab at a dose of 375 mg Q3W on Day 1 of each 21-day treatment cycle.
    id
    EG008
    other Num Affected
    1
    other Num At Risk
    5
    serious Num Affected
    2
    serious Num At Risk
    5
    title
    Cohort 6 - HNSCC (TTX-030 + Budigalimab)
  10. deaths Num Affected
    10
    deaths Num At Risk
    23
    description
    Participants in Cohort 8 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab at a dose of 375 mg Q3W on Day 1 of each 21-day treatment cycle.
    id
    EG009
    other Num Affected
    23
    other Num At Risk
    23
    serious Num Affected
    10
    serious Num At Risk
    23
    title
    Cohort 8 - GEC (TTX-030 + Budigalimab)
  11. deaths Num Affected
    2
    deaths Num At Risk
    8
    description
    Participants in Cohort 10 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus pembrolizumab at a dose of 200 mg Q3W on Day 1 of each 21-day treatment cycle.
    id
    EG010
    other Num Affected
    8
    other Num At Risk
    8
    serious Num Affected
    3
    serious Num At Risk
    8
    title
    Cohort 10 - UCC (TTX-030 + Pembrolizumab)
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      44
      num Events
      11
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      25
      num Events
      1
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      6
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      5
      num At Risk
      28
      num Events
      5
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      17
      num Events
      3
    8. group Id
      EG007
      num Affected
      3
      num At Risk
      14
      num Events
      3
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      7
      num At Risk
      23
      num Events
      7
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      44
      num Events
      9
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      25
      num Events
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      7
      num At Risk
      28
      num Events
      7
    7. group Id
      EG006
      num Affected
      4
      num At Risk
      17
      num Events
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      14
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      23
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Alanine aminotransferase increased
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      1
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      44
      num Events
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      25
      num Events
      1
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      6
      num Events
      2
    5. group Id
      EG004
      num Affected
      5
      num At Risk
      7
      num Events
      5
    6. group Id
      EG005
      num Affected
      12
      num At Risk
      28
      num Events
      12
    7. group Id
      EG006
      num Affected
      6
      num At Risk
      17
      num Events
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      14
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      23
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Alopecia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      8
      num Events
      2
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      44
      num Events
      9
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      25
      num Events
      7
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      6
      num Events
      2
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      7
      num Events
      2
    6. group Id
      EG005
      num Affected
      15
      num At Risk
      28
      num Events
      15
    7. group Id
      EG006
      num Affected
      7
      num At Risk
      17
      num Events
      7
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      14
      num Events
      0
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      5
      num Events
      1
    10. group Id
      EG009
      num Affected
      4
      num At Risk
      23
      num Events
      4
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      8
      num Events
      1
    term
    Anemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      44
      num Events
      8
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      25
      num Events
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      9
      num At Risk
      28
      num Events
      9
    7. group Id
      EG006
      num Affected
      4
      num At Risk
      17
      num Events
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      14
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      23
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Aspartate aminotransferase increased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      44
      num Events
      18
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      25
      num Events
      5
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      6
      num Events
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      7
      num Events
      1
    6. group Id
      EG005
      num Affected
      6
      num At Risk
      28
      num Events
      6
    7. group Id
      EG006
      num Affected
      6
      num At Risk
      17
      num Events
      6
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      14
      num Events
      2
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      7
      num At Risk
      23
      num Events
      7
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      8
      num Events
      1
    term
    Constipation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      44
      num Events
      7
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      25
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      28
      num Events
      1
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      17
      num Events
      2
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      14
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      6
      num At Risk
      23
      num Events
      6
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      8
      num Events
      1
    term
    Cough
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      1
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      44
      num Events
      10
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      25
      num Events
      7
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
      num Events
      1
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      7
      num Events
      2
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      28
      num Events
      3
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      17
      num Events
      2
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      14
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      23
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    COVID-19
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      1
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      44
      num Events
      19
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      25
      num Events
      8
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      6
      num Events
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      10
      num At Risk
      28
      num Events
      10
    7. group Id
      EG006
      num Affected
      7
      num At Risk
      17
      num Events
      7
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      14
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      10
      num At Risk
      23
      num Events
      10
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Decreased appetite
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      1
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      44
      num Events
      19
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      25
      num Events
      6
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      6
      num Events
      2
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      7
      num Events
      2
    6. group Id
      EG005
      num Affected
      10
      num At Risk
      28
      num Events
      10
    7. group Id
      EG006
      num Affected
      5
      num At Risk
      17
      num Events
      5
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      14
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      23
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Diarrhea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      44
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
      num Events
      1
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      7
      num Events
      2
    6. group Id
      EG005
      num Affected
      8
      num At Risk
      28
      num Events
      8
    7. group Id
      EG006
      num Affected
      4
      num At Risk
      17
      num Events
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      14
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      6
      num At Risk
      23
      num Events
      6
    11. group Id
      EG010
      num Affected
      2
      num At Risk
      8
      num Events
      2
    term
    Edema peripheral
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      8
      num Events
      2
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      44
      num Events
      17
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      25
      num Events
      6
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      6
      num Events
      2
    5. group Id
      EG004
      num Affected
      7
      num At Risk
      7
      num Events
      7
    6. group Id
      EG005
      num Affected
      18
      num At Risk
      28
      num Events
      18
    7. group Id
      EG006
      num Affected
      11
      num At Risk
      17
      num Events
      11
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      14
      num Events
      2
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      11
      num At Risk
      23
      num Events
      11
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Fatigue
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      44
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      28
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      17
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      14
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      23
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      44
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      28
      num Events
      1
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      17
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      14
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      23
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Anemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      44
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      28
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      17
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      14
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      23
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Blood loss anemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      44
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      28
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      17
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      14
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      23
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      44
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      28
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      17
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      14
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      23
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Atrial fibrillation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      44
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      28
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      17
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      14
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      23
      num Events
      1
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Hypophysitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      44
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      25
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      28
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      17
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      14
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      23
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Gastric haemorrhage
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      44
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      25
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      28
      num Events
      1
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      17
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      14
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      23
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Gastrointestinal haemorrhage
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      44
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      25
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      28
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      17
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      14
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      23
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Obstruction gastric
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      44
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      28
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      17
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      14
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      23
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Small intestinal obstruction
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      44
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      28
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      17
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      14
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      23
      num Events
      1
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Abdominal pain upper
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      44
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      28
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      17
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      14
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      23
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Anal fistula
time Frame
Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice