Table 3.

DAIDS Grade 3/4 adverse events^a: highest-grade event(s) per patient organized by class and final chemotherapy regimen^b

Class	Event	Bleomycin plus vincristine (N=70)	First-line paclitaxel (N=20)	Second-line paclitaxelc (N=24)	p
Haematologic (n)
	Neutropenia	9	3d	2
	Anaemia	4	0	2
	Thrombocytopenia	0	1	1
	Sub-total	13	4	5
Hepatic (n)
	ALT/AST elevation	1	0	0
	Sub-total	1	0	0
Cardiac (n)
	Symptomatic hypotension requiring IV fluids	0	0	1e
	Sub-total	0	0	1
Multiple events (n)
	Recurrent neutropenia	0	0	3
	Neutropenia & anaemia	1	0	0
	Neutropenia, anaemia, & ALT/AST elevation	1f	0	0
	Neutropenia, thrombocytopenia, & ALT/AST elevation	0	0	1g
	Sub-total	2	0	4
Total n (%)		16 (23%)	4 (20%)	10 (42%)	0.04h

^aDAIDS, Division of AIDS table for grading the severity of adult and paediatric adverse events version 1.0, December, 2004; Clarification August 2009 (www.rsc.tech-res.com/Document/safetyandpharmacovigilance/Table_for_Grading_Severity_of_Adult_Pediatric_Adverse_Events.pdf)

^bThe table lists the highest-grade, mutually exclusive grade 3/4 event or combination of events (i.e. “multiple events”) experienced by each patient, organized by final chemotherapy regimen and adverse event class. All adverse events were at least possibly related to chemotherapy based on U.S. National Cancer Institute nomenclature, unless otherwise indicated (www.ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/aeguidelines.pdf)

^cincludes any DAIDS grade 3/4 event occurring from BV initiation through the last cycle of second-line paclitaxel

^dincludes one confirmed episode of fever and neutropenia that resolved with antibiotic treatment

^edefinitely related to second-line paclitaxel (based on U.S. National Cancer Institute nomenclature), as the event occurred during paclitaxel infusion and resolved with stopping paclitaxel

^fpatient developed grade 3 ALT elevation followed by grade 3 anaemia and grade 4 neutropenia

^gpatient developed grade 3 AST elevation and grade 3 neutropenia while receiving BV. Patient also developed grade 3 thrombocytopenia during treatment with second-line paclitaxel

^hp value is for the overall association between final chemotherapy regimen and grade 3 or 4 severe adverse event(s). A significantly greater proportion of patients who received second-line paclitaxel experienced ≥1 grade 3 or 4 adverse event compared to patients who received bleomycin plus vincristine only (p=0.01). A non-significantly greater proportion of patients who received second-line paclitaxel experienced ≥1 grade 3 or 4 adverse event compared to patients who received first-line paclitaxel (p=0.06).

ALT (SGPT): alanine aminotransferase; AST (SGOT): aspartate aminotransferase; IV: intravenous.