Table 3. Open in new tab Adverse events...

Treatment arm

Adverse event

Grade 2

Grade 3

Grade 4

Arm A (Carbo/Taxol + Ipat), n = 7 (excluding 3 patients at 400 mg)

All arm A events

7 (100%)

5 (71%)

0 (0%)

Diarrhea

5 (71%)

1 (14%)

Leukopenia

3 (43%)

2 (29%)

Lymphopenia

1 (14%)

2 (29%)

Neutropenia

4 (57%)

2 (29%)

Anemia

4 (57%)

Mucositis, oral

1 (14%)^a

Peripheral sensory neuropathy

3 (43%)

1 (14%)^a

Nausea/vomiting

1 (14%)

Thrombocytopenia

1 (14%)

Hyperglycemia

2 (29%)

Anorexia

1 (14%)

Arm B (Carbo + Ipat), n = 12

All Arm B events

11 (92%)

5 (42%)

1 (8%)

Diarrhea

5 (42%)

2 (17%)^b

Lymphopenia

2 (17%)

1 (8%)

Leukopenia

5 (42%)

Anemia

5 (42%)

1 (8%)

Hyperglycemia

1 (8%)

1 (8%)^b

Dry mouth

1 (8%)

Dyspepsia

1 (8%)

Fatigue

2 (17%)

Fever

1 (8%)

Flushing

1 (8%)

Gastroesophageal reflux disease

1 (8%)

Hypertension

1 (8%)

Hypoalbuminemia

1 (8%)

Hypomagnesemia

1 (8%)

Hypophosphatemia

1 (8%)

Mucositis, oral

1 (8%)

Nausea/vomiting

1 (8%)

Neutropenia

6 (50%)

Pain

1 (8%)

Thrombocytopenia

2 (17%)

Restlessness

1 (8%)

Nail infection

1 (8%)

Rash, maculopapular

1 (8%)

Arm C (Cape +Ipat + Atezo), n = 6

All Arm C events

4 (67%)

3 (50%)

0 (0%)

Anemia

1 (17%)

Anorexia

1 (17%)

Arthralgia

1 (17%)

Diarrhea

1 (17%)

Fatigue

1 (17%)

1 (17%)^c

Fever

1 (17%)

Lymphopenia

2 (33%)

Leukopenia

1 (17%)

Neutropenia

2 (33%)

Malaise

1 (17%)

Pain

1 (17%)

Pain in extremity

1 (17%)

Cognitive disturbance

1 (17%)^c

Rash, maculopapular

1 (17%)

Table 3.

Open in new tab

Adverse events at RP2D per CTCAE 5.0 (N = 25).

Treatment arm	Adverse event	Grade 2	Grade 3	Grade 4
Arm A (Carbo/Taxol + Ipat), n = 7 (excluding 3 patients at 400 mg)	All arm A events	7 (100%)	5 (71%)	0 (0%)
	Diarrhea	5 (71%)	1 (14%)
	Leukopenia	3 (43%)	2 (29%)
	Lymphopenia	1 (14%)	2 (29%)
	Neutropenia	4 (57%)	2 (29%)
	Anemia	4 (57%)
	Mucositis, oral		1 (14%)^a
	Peripheral sensory neuropathy	3 (43%)	1 (14%)^a
	Nausea/vomiting	1 (14%)
	Thrombocytopenia	1 (14%)
	Hyperglycemia	2 (29%)
	Anorexia	1 (14%)
Arm B (Carbo + Ipat), n = 12	All Arm B events	11 (92%)	5 (42%)	1 (8%)
	Diarrhea	5 (42%)	2 (17%)^b
	Lymphopenia	2 (17%)	2 (17%)	1 (8%)
	Leukopenia	5 (42%)
	Anemia	5 (42%)	1 (8%)
	Hyperglycemia	1 (8%)	1 (8%)^b
	Dry mouth	1 (8%)
	Dyspepsia	1 (8%)
	Fatigue	2 (17%)
	Fever	1 (8%)
	Flushing	1 (8%)
	Gastroesophageal reflux disease	1 (8%)
	Hypertension	1 (8%)
	Hypoalbuminemia	1 (8%)
	Hypomagnesemia	1 (8%)
	Hypophosphatemia	1 (8%)
	Mucositis, oral	1 (8%)
	Nausea/vomiting	1 (8%)
	Neutropenia	6 (50%)
	Pain	1 (8%)
	Thrombocytopenia	2 (17%)
	Restlessness	1 (8%)
	Nail infection	1 (8%)
	Rash, maculopapular		1 (8%)
Arm C (Cape +Ipat + Atezo), n = 6	All Arm C events	4 (67%)	3 (50%)	0 (0%)
	Anemia	1 (17%)	1 (17%)
	Anorexia	1 (17%)
	Arthralgia	1 (17%)
	Diarrhea	1 (17%)
	Fatigue	1 (17%)	1 (17%)^c
	Fever	1 (17%)
	Lymphopenia	2 (33%)
	Leukopenia	1 (17%)
	Neutropenia	2 (33%)
	Malaise	1 (17%)
	Pain	1 (17%)
	Pain in extremity	1 (17%)
	Cognitive disturbance		1 (17%)^c
	Rash, maculopapular		1 (17%)

Treatment arm	Adverse event	Grade 2	Grade 3	Grade 4
Arm A (Carbo/Taxol + Ipat), n = 7 (excluding 3 patients at 400 mg)	All arm A events	7 (100%)	5 (71%)	0 (0%)
	Diarrhea	5 (71%)	1 (14%)
	Leukopenia	3 (43%)	2 (29%)
	Lymphopenia	1 (14%)	2 (29%)
	Neutropenia	4 (57%)	2 (29%)
	Anemia	4 (57%)
	Mucositis, oral		1 (14%)^a
	Peripheral sensory neuropathy	3 (43%)	1 (14%)^a
	Nausea/vomiting	1 (14%)
	Thrombocytopenia	1 (14%)
	Hyperglycemia	2 (29%)
	Anorexia	1 (14%)
Arm B (Carbo + Ipat), n = 12	All Arm B events	11 (92%)	5 (42%)	1 (8%)
	Diarrhea	5 (42%)	2 (17%)^b
	Lymphopenia	2 (17%)	2 (17%)	1 (8%)
	Leukopenia	5 (42%)
	Anemia	5 (42%)	1 (8%)
	Hyperglycemia	1 (8%)	1 (8%)^b
	Dry mouth	1 (8%)
	Dyspepsia	1 (8%)
	Fatigue	2 (17%)
	Fever	1 (8%)
	Flushing	1 (8%)
	Gastroesophageal reflux disease	1 (8%)
	Hypertension	1 (8%)
	Hypoalbuminemia	1 (8%)
	Hypomagnesemia	1 (8%)
	Hypophosphatemia	1 (8%)
	Mucositis, oral	1 (8%)
	Nausea/vomiting	1 (8%)
	Neutropenia	6 (50%)
	Pain	1 (8%)
	Thrombocytopenia	2 (17%)
	Restlessness	1 (8%)
	Nail infection	1 (8%)
	Rash, maculopapular		1 (8%)
Arm C (Cape +Ipat + Atezo), n = 6	All Arm C events	4 (67%)	3 (50%)	0 (0%)
	Anemia	1 (17%)	1 (17%)
	Anorexia	1 (17%)
	Arthralgia	1 (17%)
	Diarrhea	1 (17%)
	Fatigue	1 (17%)	1 (17%)^c
	Fever	1 (17%)
	Lymphopenia	2 (33%)
	Leukopenia	1 (17%)
	Neutropenia	2 (33%)
	Malaise	1 (17%)
	Pain	1 (17%)
	Pain in extremity	1 (17%)
	Cognitive disturbance		1 (17%)^c
	Rash, maculopapular		1 (17%)

^aOne patient had both grade 3 oral mucositis and grade 3 peripheral sensory neuropathy.

^bOne patient had both grade 3 diarrhea and grade 3 hyperglycemia.

^cOne patient had both grade 3 fatigue and grade 3 cognitive disturbance.

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